Carapace Debridement Kits

FDA 510(k) K931669 · Carapace, Inc.

Unknown

510(k) numberK931669

Submission

Device name
Carapace Debridement Kits
Applicant
Carapace, Inc.
Broken Arrow, OK, US
Received
April 6, 1993
Decision date
February 7, 1994
Decision
Unknown (SESK)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
FRG – Wrap, Sterilization
Device class
Class II (moderate risk)
Regulation
21 CFR 880.6850
Specialty
General Hospital

Other 510(k)s with product code FRG

510(k)DeviceApplicantDecision
K261897HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD*…FRG · Traditional O&M Halyard, Inc.07/02/2026SE
K252823Dukal Crepe Paper Sterilization WrapFRG · Traditional Dukal, LLC05/28/2026SE
K253454HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap…FRG · Traditional O&M Halyard, Inc.05/18/2026SE
K251347Sterilization Pouch/RollFRG · Traditional Sterivic Medical Co., Ltd.01/28/2026SE
K251177Self-Seal Sterilization Pouch and RollFRG · Traditional Guangdong Maidi Medical Co., Ltd.12/12/2025SE
K250306Chex-All Sterilization Pouches and TubesFRG · Abbreviated Propper Manufacturing Co., Inc.10/31/2025SE
K243179Sterilization Pouch and RollFRG · Traditional Yichang Xinxin Paper Products Co., Ltd.06/26/2025SE
K250321GCI Sterilization WrappersFRG · Traditional George Courey, Inc.06/06/2025SE
K243721Self Sealing Sterilization PouchesFRG · Traditional Wellmed Dental Medical Supply Co., Ltd.04/25/2025SE
K250011Turbett Surgical Instrument Pod (TS1500); Turbett Surgical Instrument Pod (TS1200)…FRG · Traditional Turbett Surgical04/04/2025SE

More from Turbett Surgical

510(k)DeviceDecision
K931722Carapace Labor and Delivery SetsMLS · Traditional 03/23/1994SEKD
K931822Carapace Pelvic Exam TraysMLT · Traditional 03/07/1994SESK
K931729I.V. Start KitFOZ · Traditional 02/22/1994SEKD
K931820Carapace Stillwater Bowl SetLRO · Traditional 02/07/1994SESK
K931760Carapace Packing Gauze TraysLRO · Traditional 02/04/1994SESK
K932653Swisstek 2000(TM) Cast Removal SystemLGH · Traditional 01/28/1994SE
K931819Carapace Suture Removal TraysIRO · Traditional 01/26/1994SEKD
K931758Carapace Wound Dressing Kits & Laceration TraysLRO · Traditional 01/26/1994SEKD
K931759Carapace Sterile Gauze TraysLRO · Traditional 01/25/1994SESK
K931670Carapace Epidural Block & Spinal Myelogram TraysCAZ · Traditional 01/25/1994SE

Questions and answers

When was Carapace Debridement Kits cleared by the FDA?

Carapace Debridement Kits (K931669) received a 510(k) decision of Unknown on February 7, 1994, 307 days after the submission was received.

What is the product code of K931669?

The FDA product code is FRG – Wrap, Sterilization, a Class II (moderate risk) device regulated under 21 CFR 880.6850.