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510(k) K891402

UTERINE CLAMPS by Zinnanti Surgical Instruments, Inc. — Product Code HGC

K891402 is an FDA 510(k) premarket notification submitted by Zinnanti Surgical Instruments, Inc. for the device "UTERINE CLAMPS". The FDA issued a decision of Substantially Equivalent on March 29, 1989. The device falls under product code HGC (Clamp, Uterine), a Class I device regulated under 21 CFR 884.4520. Zinnanti Surgical Instruments, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 29, 1989
Date Received
March 14, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Clamp, Uterine
Device Class
Class I
Regulation Number
884.4520
Review Panel
OB
Submission Type

Other clearances by Zinnanti Surgical Instruments, Inc.

  • K925501 — NYLON COATED SPECULA (June 13, 1997)
  • K941458 — UTERINE MANIPULATOR/INJECTOR WITH SPRING (January 25, 1995)
  • K941457 — UTERINE INJECTOR WITH SPRING (January 24, 1995)
  • K925560 — ZSI LOOP, ZSI BALL & ZSI NEEDLE ELECTRODES (August 30, 1994)
  • K925957 — SCISSORS FOR LAPAROSCOPIC SURGERY OB/GYN USE (June 7, 1994)
  • K925960 — FORCEPS FOR LAPAROSCOPIC SURGERY OB/GYN USE (June 7, 1994)
  • K926021 — NEEDLE HOLDERS & ACCESS FOR LAPAR SURG-OB/GYN USE (April 7, 1994)
  • K925958 — SCISSOR FOR LAPAROSCOPIC SURGERY GU USE (March 24, 1994)
  • K926181 — ZSI LAPAROSCOPES-GENERAL & PLASTIC SURGERY (December 17, 1993)
  • K925959 — FORCEPS FOR LAPAROSCOPIC SURGERY GU USE (November 12, 1993)

Other clearances for product code HGC

  • K771344 — GUSBERG HYSTERECTOMY CLAMP (July 27, 1977)

FDA data resources