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510(k) K811632

UNSTERILIZED LAPAROTOMY SPONGES (CHINA) by Robert I. Chien & Assoc., Inc. — Product Code GDY

K811632 is an FDA 510(k) premarket notification submitted by Robert I. Chien & Assoc., Inc. for the device "UNSTERILIZED LAPAROTOMY SPONGES (CHINA)". The FDA issued a decision of Substantially Equivalent on September 11, 1981. The device falls under product code GDY (Gauze/Sponge, Internal, X-Ray Detectable), a Class I device regulated under 21 CFR 878.4450. Robert I. Chien & Assoc., Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 11, 1981
Date Received
June 9, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gauze/Sponge, Internal, X-Ray Detectable
Device Class
Class I
Regulation Number
878.4450
Review Panel
SU
Submission Type

Other clearances by Robert I. Chien & Assoc., Inc.

  • K822151 — SURGICAL INSTRUMENTS REPRESENT. 4 CLASS (August 19, 1982)
  • K811631 — THERMOMETER (MADE IN CHINA) (July 20, 1981)
  • K810054 — RICA (DIAGNOSTIC INSTRUMENTS) (January 28, 1981)
  • K801819 — SURGICAL INSTRUMENTS (August 20, 1980)
  • K801028 — RICA OR SMIC SURGICAL INSTRUMENTS (May 20, 1980)

Other clearances for product code GDY

  • K972634 — ULTRACELL SUCTION SPONGE (December 17, 1997)
  • K960236 — CPR LAP SPONGES (March 28, 1996)
  • K955599 — STRYKER FEMORAL CANAL SPONGE & ACETABULUM SPONGE (February 22, 1996)
  • K955322 — PROTEC X-RAY DETECTABLE GAUZE SPONGE (December 19, 1995)
  • K953830 — KENSORB (October 3, 1995)
  • K953088 — TRIANGULAR SPONGES (September 14, 1995)
  • K953060 — ROSEBUD DISSECTOR (September 14, 1995)
  • K953087 — CHERRY PIT DISSECTOR (September 14, 1995)
  • K953062 — CHERRY DISSECTOR (September 14, 1995)
  • K953059 — KITTNER DISSECTOR (September 14, 1995)

FDA data resources