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510(k) K892542

RECTAL SPECULA - CHELSEA-EATON, KELLY, MATHIEU by Zinnanti Surgical Instruments, Inc. — Product Code FFN

K892542 is an FDA 510(k) premarket notification submitted by Zinnanti Surgical Instruments, Inc. for the device "RECTAL SPECULA - CHELSEA-EATON, KELLY, MATHIEU". The FDA issued a decision of Substantially Equivalent on May 9, 1989. The device falls under product code FFN (Clamp, Non-Electrical), a Class I device regulated under 21 CFR 876.4730. Zinnanti Surgical Instruments, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 1989
Date Received
April 11, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Clamp, Non-Electrical
Device Class
Class I
Regulation Number
876.4730
Review Panel
GU
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 FFN

  • K932408 — AMBULATORY INFUSION PUMP SYSTEM AND SOLUTION SETS (September 28, 1993)
  • K892550 — BEST COLON CLAMP (May 9, 1989)
  • K772405 — TUBING CLAMP (January 26, 1978)
  • K771421 — CATHETEO CLAMP (October 25, 1977)

FDA data resources