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510(k) K983538

MINIATURIZED BIOPSY,SCOPE A.K.A: BIOPSY NEEDLE WITH ENDOSCOPIC VIEWING CAPABILITY by Solos Endoscopy, Inc. — Product Code GCJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 6, 1998
Date Received
October 9, 1998
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laparoscope, General & Plastic Surgery
Device Class
Class II
Regulation Number
876.1500
Review Panel
SU
Submission Type

Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Other clearances by Solos Endoscopy, Inc.

  • K910671 — MODEL GS-4700 COMMON DUCT STONE REMOVING KIT (May 10, 1991)
  • K900957 — GS-2100 HOOK SUTURE SCISSOR, 5MM (April 18, 1990)
  • K900963 — GS-4350 TROCAR ONLY, 5.5MM (April 18, 1990)
  • K900956 — GS-7100 CHOLANGIOGRAM CLAMP, 5MM (April 18, 1990)
  • K900947 — GS-1000 GRASPING FORCEP, 5MM, INSULATED (April 18, 1990)
  • K900958 — GS-1300 ATRAUMATIC GRASPING FORCEP, CURVED, 10MM (April 18, 1990)
  • K900961 — GS-4100 REDUCER SLEEVE, 5MM TO 3MM (April 18, 1990)
  • K900953 — GS-5000 SPATULA SUCTION/COAGULATOR, 5MM (April 18, 1990)
  • K900951 — GS-7000 CLIP-APPLYING FORCEP, 10MM, MEDIUM CLIP (April 18, 1990)
  • K900962 — GS-4300 CANNULA AND TROCAR, 5.5MM (April 18, 1990)

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