Home / 510(k) Clearances / K822623

510(k) K822623

LAPAROTOMY SPONGE by Hermitage Hospital Products, Inc. — Product Code GDY

K822623 is an FDA 510(k) premarket notification submitted by Hermitage Hospital Products, Inc. for the device "LAPAROTOMY SPONGE". The FDA issued a decision of Substantially Equivalent on October 13, 1982. The device falls under product code GDY (Gauze/Sponge, Internal, X-Ray Detectable), a Class I device regulated under 21 CFR 878.4450. Hermitage Hospital Products, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 13, 1982
Date Received
August 30, 1982
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 Hermitage Hospital Products, Inc.

  • K941802 — OR TOWEL (May 3, 1995)
  • K923115 — CLINISORB (November 23, 1992)
  • K923116 — COMBINE II WETPROOF PAD (October 6, 1992)
  • K891324 — HERMITEX SPONGE (April 27, 1989)
  • K863737 — SPONGES STERILE TWIN PAKT AND SINGLES (October 14, 1986)
  • K843788 — CUSTOM BURN DRESSING KIT (November 7, 1984)
  • K822987 — DRESSING SPONGE (November 5, 1982)

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)
  • K953059 — KITTNER DISSECTOR (September 14, 1995)
  • K953062 — CHERRY DISSECTOR (September 14, 1995)

FDA data resources