Product code GCS— Gastroenterology, Urology

FDA has cleared 9 devices under product code GCS between 1992 and 1995, filed by 8 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.

• 19951 clearance
• 19941 clearance
• 19936 clearances
• 19921 clearance

• Inman Medical Corp.2 clearances
• M.I.S. Technology, Inc.1 clearance
• Leisegang Medical, Inc.1 clearance
• Laparomed Corp.1 clearance
• Instrument Makar, Inc.1 clearance
• Ideal Medical, Inc.1 clearance
• Baxter Healthcare Corp1 clearance
• Aesculap, Inc.1 clearance

• K944062 — LAPRASCOPIC GRASPERInstrument Makar, Inc.·1995-02-23
• K944067 — PEANUT WAND, MODIFICATIONIdeal Medical, Inc.·1994-12-08
• K933201 — AESCULAP TROCAR INSTRUMENT SETAesculap, Inc.·1993-09-13
• K932762 — 10.0MM SUCTION/IRRIGATION PROBE & TUBING KITInman Medical Corp.·1993-08-31
• K933371 — IMC ENDOSCOPIC INSTRUMENT HOLDERInman Medical Corp.·1993-08-06
• K924134 — LEISEGANG LAPAROSCOPIC IRRIGATION SYSTEM/ACCESSLeisegang Medical, Inc.·1993-07-02
• K931340 — GRASP FORCEPS/SCISSORS/NEEDLE HOLDER/DISSECTORBaxter Healthcare Corp·1993-07-01
• K925276 — M.I.S. TROCAR-CANNULAM.I.S. Technology, Inc.·1993-05-24
• K921006 — LAPAROSCOPIC RETRACTOR SYSTEMLaparomed Corp.·1992-07-28