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510(k) K915372

MANUAL SURGICAL INSTRMENTS FOR LAPAROSCOPY by Unisurge, Inc. — Product Code GCJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 6, 1992
Date Received
November 27, 1991
Clearance Type
Traditional
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 Unisurge, Inc.

  • K943502 — UNIGRIP (October 7, 1994)
  • K933720 — INSTRUMENT ACTUATING DEVICE (IAD) (November 12, 1993)
  • K930605 — APPLIER, SURGICAL, CLIP (October 8, 1993)
  • K930617 — OBGRIP AND UNITIPS(TM) (August 11, 1993)
  • K925882 — UNITIPS SURGICAL INSTRUMENTS (August 10, 1993)
  • K932604 — UNIGRIP-FH SURGICAL HANDPIECE/LAPAROSCOPIC (August 10, 1993)
  • K925917 — UNICHANNEL(TM SURGICAL GRASPER (August 10, 1993)
  • K930809 — UNITIPS (August 10, 1993)
  • K926341 — UNITROCAR(TM) REUSABLE SURG TROCAR/RESUSE KIT (May 17, 1993)
  • K926199 — UNICLIP SURGICAL CLIP APPLIER (April 20, 1993)

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