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510(k) K900950

GS-2000 MICRO SCISSOR, CURVED LEFT, 5MM by Solos Endoscopy, Inc. — Product Code LRW

K900950 is an FDA 510(k) premarket notification submitted by Solos Endoscopy, Inc. for the device "GS-2000 MICRO SCISSOR, CURVED LEFT, 5MM". The FDA issued a decision of Substantially Equivalent on April 18, 1990. The device falls under product code LRW (Scissors, General, Surgical), a Class I device regulated under 21 CFR 878.4800. Solos Endoscopy, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 18, 1990
Date Received
February 27, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Scissors, General, Surgical
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Solos Endoscopy, Inc.

  • K983538 — MINIATURIZED BIOPSY,SCOPE A.K.A: BIOPSY NEEDLE WITH ENDOSCOPIC VIEWING CAPABILIT (November 6, 1998)
  • K910671 — MODEL GS-4700 COMMON DUCT STONE REMOVING KIT (May 10, 1991)
  • K900954 — GS-5200 HOOK SUCTION/COAGULATOR, 5MM (April 18, 1990)
  • K900955 — GS-4000 REDUCER SLEEVE, 11MM TO 5MM (April 18, 1990)
  • K900961 — GS-4100 REDUCER SLEEVE, 5MM TO 3MM (April 18, 1990)
  • K900959 — GS-1400 TOOTHED DISSECTING FORCEP, 5MM, INSULATED (April 18, 1990)
  • K900949 — GS-1100 MICRO DISSECTING FORCEP, 5MM, INSULATED (April 18, 1990)
  • K900951 — GS-7000 CLIP-APPLYING FORCEP, 10MM, MEDIUM CLIP (April 18, 1990)
  • K900963 — GS-4350 TROCAR ONLY, 5.5MM (April 18, 1990)
  • K900956 — GS-7100 CHOLANGIOGRAM CLAMP, 5MM (April 18, 1990)

Other clearances for product code LRW

  • K911158 — MICRO SCISSORS, 5MM CURVE MICRO SCISSORS, 5MM (March 29, 1991)
  • K902828 — SUTURE REMOVAL TRAY (August 8, 1990)
  • K900957 — GS-2100 HOOK SUTURE SCISSOR, 5MM (April 18, 1990)
  • K892823 — PLASTER CUTTING SCISSORS (May 25, 1989)
  • K891889 — OLIVECORONA SCISSORS (April 12, 1989)
  • K891886 — SCISSORS, VARIOUS TYPES (April 12, 1989)
  • K891200 — RIBBON TYPE SCISSORS: TENOTOMY,IRIS,EYE,STRABISMUS (April 6, 1989)
  • K891203 — SCISSORS: THOREK, JORGENSEN, FINOCHIETTO (April 6, 1989)
  • K890170 — SCISSORS (February 3, 1989)
  • K890235 — DRESSING SCISSORS (February 3, 1989)

FDA data resources