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510(k) K932036

LACERATION TRAY by Clinipad Corp. — Product Code FRG

K932036 is an FDA 510(k) premarket notification submitted by Clinipad Corp. for the device "LACERATION TRAY". The FDA issued a decision of Substantially Equivalent (kit) on December 13, 1993. The device falls under product code FRG (Wrap, Sterilization), a Class II device regulated under 21 CFR 880.6850. Clinipad Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
December 13, 1993
Date Received
April 27, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wrap, Sterilization
Device Class
Class II
Regulation Number
880.6850
Review Panel
HO
Submission Type

Other clearances by Clinipad Corp.

  • K931560 — CARDIAC CATHETERIZATION TRAY (July 11, 1994)
  • K931668 — PICC INSERTION TRAY (March 7, 1994)
  • K932071 — I.V. START KIT (February 17, 1994)
  • K932010 — V.A.D. ACCESS KIT (February 3, 1994)
  • K932016 — TRACHEOSTOMY CARE TRAY (November 3, 1993)
  • K862562 — PUNCH BIOPSY KIT (October 7, 1986)
  • K862563 — TRACHEOSTOMY CLEANSING SOLUTION (July 15, 1986)
  • K833075 — WET DRESSING KIT (January 27, 1984)
  • K833432 — CATHETER INSERTION KIT (December 28, 1983)
  • K830476 — OR PREP KIT (March 31, 1983)

Other clearances for product code FRG

  • K261897 — HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* HE (July 2, 2026)
  • K252823 — Dukal Crepe Paper Sterilization Wrap (May 28, 2026)
  • K253454 — HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap; (May 18, 2026)
  • K251347 — Sterilization Pouch/Roll (January 28, 2026)
  • K251177 — Self-Seal Sterilization Pouch and Roll (December 12, 2025)
  • K250306 — Chex-All Sterilization Pouches and Tubes (October 31, 2025)
  • K243179 — Sterilization Pouch and Roll (June 26, 2025)
  • K250321 — GCI Sterilization Wrappers (June 6, 2025)
  • K243721 — Self Sealing Sterilization Pouches (April 25, 2025)
  • K250011 — Turbett Surgical Instrument Pod (TS1500); Turbett Surgical Instrument Pod (TS120 (April 4, 2025)

FDA data resources