Product code GET— General, Plastic Surgery

FDA has cleared 23 devices under product code GET between 1979 and 1996, filed by 14 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

• 19962 clearances
• 19956 clearances
• 19921 clearance
• 19911 clearance
• 19901 clearance
• 19891 clearance
• 19871 clearance
• 19861 clearance
• 19842 clearances
• 19835 clearances
• 19801 clearance
• 19791 clearance

• Midas Rex Pneumatic Tools, Inc.5 clearances
• Amsco Co.4 clearances
• United States Surgical, A Division of Tyco Healthc2 clearances
• Surgical Dynamics, Inc.2 clearances
• Surgical Mechanical Research, Inc.1 clearance
• Suncoast Medical Manufacturers, Inc.1 clearance
• Stryker Corp.1 clearance
• Sodem Diffusion SA1 clearance
• Sen Tech Medical Corp.1 clearance
• Micro-Aire Surgical Instruments, Inc.1 clearance

• K960473 — AESCULAP POWER SYSTEM HANDPIECEAesculap, Inc.·1996-03-07
• K955174 — SODEM HIGH SPEED SYSTEM FOR NEUROSURGERY & MEDIAN STYERNOTOMYSodem Diffusion SA·1996-01-22
• K942987 — NUCLEOTOME L KITSurgical Dynamics, Inc.·1995-10-30
• K954076 — MIDAS REX DRILL ATTACHMENTS & TWIST DRILLSMidas Rex Pneumatic Tools, Inc.·1995-10-18
• K953433 — MIDAS REX TELESCOPING SYSTEMMidas Rex Pneumatic Tools, Inc.·1995-09-15
• K953432 — ROTATING, FIXED FOOTED, FIXED SHIELD ATTACHMENTS, DISSECTING TOOLSMidas Rex Pneumatic Tools, Inc.·1995-09-14
• K952463 — GS & GS20 SURGICAL TOOL SYSTEMMidas Rex Pneumatic Tools, Inc.·1995-07-17
• K952300 — MIDAS REX MOTORS (MIDAS I, II & CONVERTIBLE MODELS)Midas Rex Pneumatic Tools, Inc.·1995-05-26
• K914753 — AUTO SUTURE(R) ARTICULATING ENDOSCOPIC CLAMPUnited States Surgical, A Division of Tyco Healthc·1992-06-11
• K910071 — PORTA GAS COMPRESSED GAS CYLINDER CARTSen Tech Medical Corp.·1991-03-22
• K904578 — MODIFICATION AUTO SUTURE(R) ENDOSCOPIC CLAMPUnited States Surgical, A Division of Tyco Healthc·1990-10-30
• K885066 — HEMATOME SYSTEMSurgical Dynamics, Inc.·1989-05-01
• K872951 — AMERICAN BRAIN RETRACTOR COVERAmerican Silk Sutures, Inc.·1987-09-16
• K863447 — STRYKER ORTHOPOWER 90 & ORTHOPOWER 90 SYSTEM IIStryker Corp.·1986-09-29
• K843498 — BIPOLAR SUCTION ELECTRODEEder Instrument Co, Inc.·1984-12-14
• K840370 — SURG-A-STAT VASECTOMY TIPSuncoast Medical Manufacturers, Inc.·1984-07-23
• K833187 — HALL OSTEONAmsco Co.·1983-10-31
• K832186 — HALL DRILL/REAMERAmsco Co.·1983-08-12
• K832187 — HALL OSCILLATORAmsco Co.·1983-08-12
• K832188 — HALL RECIPROCATORAmsco Co.·1983-08-12
• K831675 — TWIST LOCK DRILL 1120Micro-Aire Surgical Instruments, Inc.·1983-06-30
• K800382 — CLEAR-VIEW MIRROR WARMERSurgical Mechanical Research, Inc.·1980-05-14
• K790195 — FOOT VALVEAmerican Safety·1979-02-26