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510(k) K882169

SURGICAL DUCT CLAMP (VINE) by Henley Intl. — Product Code GDJ

K882169 is an FDA 510(k) premarket notification submitted by Henley Intl. for the device "SURGICAL DUCT CLAMP (VINE)". The FDA issued a decision of Substantially Equivalent on June 17, 1988. The device falls under product code GDJ (Clamp, Surgical, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4800. Henley Intl. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 17, 1988
Date Received
May 24, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Clamp, Surgical, General & Plastic Surgery
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Henley Intl.

  • K943449 — NEUROLOGICAL DIAGNOSTIC DEVICES (November 15, 1995)
  • K926279 — UPPER BODY EXERCISER (May 5, 1994)
  • K926278 — STAIR CLIMBER (May 5, 1994)
  • K926287 — EXERCISE BICYCLE (March 22, 1994)
  • K926314 — HYDRA FITNESS MODEL 311 TOTAL POWER (March 18, 1994)
  • K926313 — COMPUTERIZED TESTING AND EXERCISE SYSTEMS (February 4, 1994)
  • K915864 — MONOTRODE CUTANEOUS ELECTRODE (July 21, 1993)
  • K922036 — SONOPULS 591 (June 29, 1993)
  • K926316 — TRUE-TRAC, STRATUS (March 24, 1993)
  • K920983 — SONOPULS 590 (March 9, 1993)

Other clearances for product code GDJ

  • K153358 — Standard Clamp (May 2, 2016)
  • K930315 — THORACIC CLAMPS: SAROT, KANTOWITZ AND LAWRENCE (February 4, 1994)
  • K924223 — MAR-MED LIVER STRAP (March 18, 1993)
  • K922659 — GENERAL SURGERY CLAMP AND NEEDLE HOLDER (July 21, 1992)
  • K914913 — GRICE FOOT PEDAL CONTROL/REDDICK IRRI/ASPIR SYST (December 31, 1991)
  • K900956 — GS-7100 CHOLANGIOGRAM CLAMP, 5MM (April 18, 1990)
  • K901107 — MODIFIED AUTO SUTURE PURSTRING DISP. AUTOMATIC (April 9, 1990)
  • K895726 — VESSEL OCCLUDER (October 24, 1989)
  • K895591 — SILICONE INSTRUMENT SHODS (October 20, 1989)
  • K881741 — STUART LEE CLIP (June 3, 1988)

FDA data resources