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510(k) K891044

LASER SPECULA by Zinnanti Surgical Instruments, Inc. — Product Code HDF

K891044 is an FDA 510(k) premarket notification submitted by Zinnanti Surgical Instruments, Inc. for the device "LASER SPECULA". The FDA issued a decision of Substantially Equivalent on March 17, 1989. The device falls under product code HDF (Speculum, Vaginal, Metal), 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 17, 1989
Date Received
February 28, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Speculum, Vaginal, Metal
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 HDF

  • K926429 — VAGINAL SPECULA: CUSCO, GUTTMAN, INFANT (February 28, 1994)
  • K902019 — MODIFIED METAL SPECULUM & SPECIAL BULLET FORCEPS (June 7, 1990)
  • K891041 — MIYA SPECULUM (March 22, 1989)
  • K890375 — VAGINAL SPECULUM (February 13, 1989)
  • K862478 — HAYES VAGINAL SHIELD (November 24, 1986)
  • K853640 — WELLINGTON HOSPITAL PATTERN SELF RETAINING VAGINAL (October 29, 1985)
  • K851799 — 61-100 TO 61-124 VARIOUS VAGINAL SPECVIA(CUSCO,GRA (May 22, 1985)
  • K843388 — WELLINGTON HOSPITAL PATTERN SELF-RETAIN (October 1, 1984)
  • K821297 — GRAVES SPECULA (May 24, 1982)
  • K821291 — PEDERSON VAGINAL SPECULA (May 24, 1982)

FDA data resources