Product code HIN— Obstetrics/Gynecology

FDA has cleared 16 devices under product code HIN between 1978 and 2014, filed by 12 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.

• 20141 clearance
• 20132 clearances
• 20122 clearances
• 20112 clearances
• 19991 clearance
• 19981 clearance
• 19942 clearances
• 19911 clearance
• 19871 clearance
• 19791 clearance
• 19782 clearances

• Richard Wolf Medical Instruments Corp.2 clearances
• Kli2 clearances
• KARL STORZ Endoscopy-America, Inc.2 clearances
• Gyrus Acmi, Inc.2 clearances
• Surgical Technologies, Inc.1 clearance
• Olympus Winter & Ibe GmbH1 clearance
• Neomed Corp.1 clearance
• Mectra Labs, Inc.1 clearance
• Lina Medical Aps1 clearance
• Everest Medical Corp.1 clearance

• K142525 — PK Lap LoopOlympus Winter & Ibe GmbH·2014-11-21
• K130305 — LINA BIPOLAR LOOP; STANDARD SIZE, LARGE SIZE, EXTRA LARGE SIZELina Medical Aps·2013-07-24
• K122983 — KSEA BIPOLAR ELECTRODEKARL STORZ Endoscopy-America, Inc.·2013-06-26
• K122605 — PKS BILLGyrus Acmi, Inc.·2012-12-05
• K113080 — TUBALGATORMectra Labs, Inc.·2012-06-29
• K111751 — VERSAPOINT II BIPOLAR ELECTROSURGERY GENERATOR, VERSAPOINT II 44MM ANGLED LOOP ELECTRODE, VERSAPOINT II FOOTSWITCH, VERSETHICON, Inc.·2011-12-02
• K111059 — GYRUS ACMIL BIPOLARLAPROSCOPIC LOOP (PKS BILL)Gyrus Acmi, Inc.·2011-09-01
• K990147 — BIPOLAR FORCEPS, KLEPPINGER INSERT, MODEL #'S 8393.741,8393.771,8394.741,8394.771Richard Wolf Medical Instruments Corp.·1999-04-16
• K971565 — BICOAG COAGULATING FORCEPSEverest Medical Corp.·1998-03-12
• K926517 — ELMED LBC 50-PElmed, Inc.·1994-11-15
• K943776 — COAGULATOR CUTTER, ENDOSCOPIC BIPOLAR AND ACCESSORIESRichard Wolf Medical Instruments Corp.·1994-11-03
• K911699 — STI TISSUE MANIPULATORSurgical Technologies, Inc.·1991-06-13
• K871745 — MODEL 26021C BIPOLAR COAGULATORKARL STORZ Endoscopy-America, Inc.·1987-07-10
• K790043 — TRACOR, CANNULA, BICEPTS BIPOLARNeomed Corp.·1979-02-08
• K781109 — FORCEPS, ELECTROSURGICALKli·1978-09-14
• K781089 — ONE INCISION BI-POLAR ELECTRO. FORCEPSKli·1978-07-17