Product code HIB— Obstetrics/Gynecology

FDA has cleared 72 devices under product code HIB between 1982 and 2026, filed by 62 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 20261 clearance
• 20142 clearances
• 20131 clearance
• 20121 clearance
• 20111 clearance
• 20101 clearance
• 20091 clearance
• 20082 clearances
• 20071 clearance
• 20064 clearances
• 20053 clearances
• 20043 clearances
• 20032 clearances
• 20028 clearances
• 20014 clearances

• Welch Allyn, Inc.3 clearances
• Sol Weiss MD, Inc.3 clearances
• C.I.S.A. Import Export C/O Larson and Taylor3 clearances
• Zinnanti Surgical Instruments, Inc.2 clearances
• Martin Medical2 clearances
• Femspec LLC2 clearances
• Exitec, Inc.2 clearances
• Zhejiang Yusheng Medical Instrument Co. , Ltd.1 clearance
• Zhejiang Gongdong Medical Plastic Factory1 clearance
• Wallach Surgical Devices, Inc.1 clearance

• K252208 — JFord Speculum SleeveFord Medtech, LLC·2026-03-06
• K133857 — BRELLA-SPEC(TM) VAGINAL SPECULUMProa Medical, Inc.·2014-04-28
• K132668 — IOB DISPOSABLE SPECULUMIob Medical, Inc.·2014-01-17
• K130046 — CLEARSPEC SINGLE USE VAGINAL SPECULUMClearspec, LLC·2013-08-06
• K120743 — SPECULUM, VAGINAL, NONMETALWelch Allyn, Inc.·2012-03-23
• K110766 — KOLPLUX SYSTEMKolplast CI Ltda·2011-09-15
• K092870 — NON-STERILE DISPOSABLE VAGINAL SPECULUMKunshan Deyi Plastic Co., Ltd.·2010-02-16
• K091937 — OFFICE-SPEC DISPOSABLE SIDE-OPENING SPECULUMObp Corporation·2009-09-09
• K072942 — MEDLINE DISPOSABLE VAGINAL SPECULUMMedline Industries, Inc.·2008-02-08
• K072762 — DEPALT VAGINAL SPECUIM AND DEPALT LIGHTING SYSTEMDepalt, Inc.·2008-01-22
• K070964 — KLEENSPEC SINGLE USE VAGINAL SPECULUM AND 790 SERIES CORDLESS ILLUMINATION SYSTEMWelch Allyn, Inc.·2007-05-18
• K061339 — HIERSPEC SPECULUMMedical Products Div.·2006-09-19
• K060129 — IGS VAGINAL SPECULUMInnovative Gynecological Solutions, LLC·2006-05-04
• K052420 — G-SPEC ARTICULATED WEIGHTED VAGINAL SPECULUMGynova, LLC·2006-04-06
• K052192 — FEMSPCE-S DISPOSABLE STERILE VAGINAL SPECULUM, MODEL ST-IFemspec LLC·2006-02-02
• K052912 — YUSHENG DISPOSABLE VAGINAL SPECULUMZhejiang Yusheng Medical Instrument Co. , Ltd.·2005-12-15
• K052314 — DYNAREX VAGINAL SPECULA 4900, MODELS 4911-SMALL, 4912-MEDIUM, 4913-LARGEDynarex Corp.·2005-11-09
• K050887 — GONGDONG DISPOSABLE VAGINAL SPECULUMZhejiang Gongdong Medical Plastic Factory·2005-07-11
• K041757 — FEMSPEC DISPOSABLE VAGINAL SPECULUMFemspec LLC·2004-12-23
• K042950 — VAG O SPECULUM, MODELS VS1, VM1, VL1Panatrex, Inc.·2004-11-30
• K040817 — POPSPEK DISPOSABLE ADJUSTABLE VAGINAL SPECULUMAdvanced Urological Developments·2004-06-22
• K030693 — KENTEX DISPOSABLE VAGINAL SPECULUMKentron Health Care, Inc.·2003-08-27
• K030761 — KAISHOU VAGINAL SPECULUMJiangsu Kaishou Medical Apparatus Co., Ltd.·2003-06-09
• K022948 — VAGINAL SPECULUM, MODEL 5555S, 5555M, OR 5555LMedical Action Industries, Inc.·2002-11-04
• K021849 — TAGG DISPOSABLE VAGINAL SPECULUMTagg Industries·2002-07-16
• K021676 — CYPRESS MEDICAL PRODUCTS, LP DISPOSABLE VAGINAL SPECULUM, NON-METALCypress Medical Products, Ltd.·2002-07-12
• K020959 — GLO-SPEC I, II AND IIISol Weiss MD, Inc.·2002-06-19
• K021017 — LEESPEC DISPOSABLE VAGINAL SPECULUMItl Corporation Pty, Ltd.·2002-06-19
• K020726 — DUKAL DISPOSABLE VAGINAL SPECULUM, SMALL, MEDIUM, AND LARGEDukal Corp.·2002-05-15
• K012535 — DRG DISPOSABLE VAGINAL SPECULUMDoctor'S Research Group, Inc.·2002-03-01
• K013835 — GLOBAL HEALTHCARE VAGINAL SPECULUMDynascend Consulting Int'L, LLC·2002-01-17
• K013817 — GLO-SPECSol Weiss MD, Inc.·2001-12-21
• K012859 — NU-SPEC DSol Weiss MD, Inc.·2001-10-26
• K002912 — VAGINAL PORT, NON-STERILE / 600065, VAGINAL PORT, STERILE / 600073Sterinc·2001-02-21
• K003540 — (DISPOSABLE) VAGINAL SPECULUMFeminica, Inc.·2001-02-09
• K000444 — MITYVIEW 4-WAY LATERAL EXPANDER SPECULUMPrism Enterprises, Inc.·2000-04-21
• K000414 — MEDISUL DISPOSABLE VAGINAL SPECULUMMarketing Perspectives·2000-04-04
• K992736 — WALLACH'S ULTIMATE REUSABLE, PLASTIC VAGINAL SPECULUMWallach Surgical Devices, Inc.·1999-09-29
• K991963 — PATTON SPECULUMPatton Medical Corp.·1999-09-01
• K991827 — GINRAM SPECUVAG, GINRAM SPECUVAG AS, GINRAM CUSCOVAG, MODELS 720101, 720102, 720103, 720179, 720227, 720043Ri Mos. S.R.L.·1999-07-19
• K983716 — VITALCARE DISPOSABLE VAGINAL SPECULUMVitalcare Group, Inc.·1998-12-23
• K984211 — MEDSCAND DISPOSABLE PLASTIC VAGINAL SPECULUM; EASY-SPEC PLASTIC VAGINAL SPECULUM, MODEL 303Medscand AB·1998-12-23
• K973853 — KOLPLAST VAGINAL SPECULUMKolplast Comercial E Industrial Ltda·1997-12-19
• K974228 — HOSPITAL'S SPECGps·1997-12-12
• K971979 — PLAYTEX TAMPONS #14897/PLAYTEX GENTLE GLIDE,SILK GLIDE, SLIMFITS,SOFT COMFORT AND PORTABLES TAMPONSPlaytex Products, Inc.·1997-09-26
• K925501 — NYLON COATED SPECULAZinnanti Surgical Instruments, Inc.·1997-06-13
• K963377 — EOS BRAND DISPOSABLE VAGINAL SPECULUM-EOSSPECNorth Eos Industries, Inc.·1996-10-04
• K951898 — VERSA-VUCooperSurgical, Inc.·1995-12-11
• K951528 — AMSINO DISPOSABLE VIGINAL SPECULUMAmsino Intl., Inc.·1995-05-11
• K941272 — KLEENSPECWelch Allyn, Inc.·1994-08-02
• K930954 — THE CABOT MEDICAL INSUL-SHETH VAGINAL SPECULUM COVCabot Medical Corp.·1994-06-30
• K922154 — INSULATED SPECULUM W/ SMOKE EVACUATOR OPTIONOlsen Electrosurgical, Inc.·1994-04-21
• K935636 — GRAVESPECAdept-Med Intl., Inc.·1994-03-25
• K933521 — SPECULUMBioteque America, Inc.·1994-03-07
• K926536 — DISPOSABLE PLASTIC VAGINAL SPECULAThomasville Medical Assoc.·1994-02-25
• K920803 — HSG TRAYUnimar, Inc.·1992-10-19
• K903080 — DISPOSABLE PLASTIC VAGINAL SPECULUMDawnex Industries, Inc.·1990-09-19
• K903744 — PHYSICIAN'S CHOICEAdvance Medical Device, Inc.·1990-09-12
• K894957 — DISPOSABLE PLASTIC VAGINAL SPECULAZinnanti Surgical Instruments, Inc.·1989-10-12
• K894489 — GYNECOLOGIC EXAMINATION KITA & A Medical, Inc.·1989-10-05
• K880586 — AUTOEXPANDABLE SPECULUM MODEL LEIBOVICH SMALL #2C.I.S.A. Import Export C/O Larson and Taylor·1988-12-20
• K880587 — AUTOEXPANDABLE SPECULUM MODEL LEIBOVICH MEDIUM #3C.I.S.A. Import Export C/O Larson and Taylor·1988-12-20
• K880588 — AUTOEXPANDABLE SPECULUM MODEL LEIBOVIC LARGE #4C.I.S.A. Import Export C/O Larson and Taylor·1988-12-20
• K882605 — EURO-MED CLEAR-VUE DISPOSABLE VAGINAL SPECULUMBuckman Co., Inc.·1988-09-15
• K863274 — MARTIN MEDICAL PRO-SPEC MEDIUM VAGINAL SPECULUMMartin Medical·1986-09-02
• K863275 — MARTIN MEDICAL PRO-SPEC SMALL VAGINAL SPECULUMMartin Medical·1986-09-02
• K842014 — HOSPITAL'S-SPECMerex Co.·1984-08-17
• K841909 — VAGINAL SPECULUM - DISPOSABLEGalenica Enterprises, Inc.·1984-07-31
• K841867 — KIDD VAGINAL SPECULUMPaul H. Schneider Ent.·1984-07-13
• K830725 — GENT-L-SPEC DISPOS. VAGINAL SPECULUMGeneva Laboratories, Inc.·1983-04-27
• K822086 — DIA-SPECExitec, Inc.·1982-11-08
• K822084 — PRO-SPECExitec, Inc.·1982-08-19