Stillwater Bowl Set

No FDA recalls found in the data synced 22 Oct 2026.

Full name

Carapace Stillwater Bowl Set

510(k) Number

K931820 ↗

FDA Product Code

LRO

Device Class

Class II

Regulation

21 CFR Part 878.4370

Advisory Committee

General, Plastic Surgery

FDA Decision

SESK Substantially Equivalent — Kit

• Various Disposable Kits/Trays/Instru

  Class I

  FDA 510(k) K840976 Active Cleared 31 May 1984

• Carapace Sterile Cotton Balls

  Class I

  FDA 510(k) K931626 Active Cleared 2 Dec 1993

• Surgical Face Mask

  Class II

  FDA 510(k) K790970 Active Cleared 3 Jul 1979

• Carapace Sterile Gauze Trays

  Class II

  FDA 510(k) K931759 Active Cleared 25 Jan 1994

• Carapace Packing Gauze Trays

  Class II

  FDA 510(k) K931760 Active Cleared 4 Feb 1994

• Carapace Instrumlent and Instrument Sets

  Class II

  FDA 510(k) K931824 Active Cleared 6 Dec 1993

See all devices from Carapace, Inc. →

• Is the Stillwater Bowl Set intended for single-use or can it be reused after sterilization?

  The Stillwater Bowl Set is designed as a single-use, non-sterile device that must be sterilized prior to use. While it is reusable after proper sterilization, it is supplied in a non-sterile state and requires terminal sterilization (e.g., autoclave or ethylene oxide) before clinical application to ensure safety and efficacy. Always follow manufacturer guidelines for sterilization to maintain performance and prevent contamination.

• What types of surgical procedures is the Stillwater Bowl Set primarily used for, and how does it help during those procedures?

  The Stillwater Bowl Set is specifically designed for general and plastic surgery procedures, where it provides a contained environment for fluid management during irrigation, debridement, and postoperative care. Its purpose is to minimize spillage, reduce contamination risks, and streamline wound care by consolidating tools and fluids in one sterile tray.

• How should the Stillwater Bowl Set be stored before use to ensure it remains sterile?

  Since the Stillwater Bowl Set is non-sterile at the time of supply, it must be sterilized before use (e.g., via autoclave or ethylene oxide). After sterilization, it should be stored in a clean, dry, and protected environment—preferably in its original packaging or a sealed, sterile barrier—until immediately before use. Avoid exposure to moisture, dust, or direct sunlight to preserve sterility and functionality.

• What regulatory pathway was followed for the FDA clearance of the Stillwater Bowl Set, and when was it cleared?

  The Stillwater Bowl Set was cleared through the traditional 510(k) pathway by the FDA in 1994 under K-number K931820. It was reviewed by the Surgical Devices Subcommittee (SU) under the General, Plastic Surgery advisory committee category and falls under FDA product code LRO (Laboratory Reagents, Ophthalmic, and Surgical Materials). The clearance reflects its classification as a surgical tray for fluid management.