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Boss Instruments 35-5167

by Boss Instruments, Ltd.

Boss Instruments 35-5167 is a Class II device made by Boss Instruments, Ltd., cleared under FDA 510(k) K040855 on 16 Apr 2004 and listed in FDA GUDID since 20 Sep 2018 (UDI-DI 00888515041318), active (FDA 510(k)), not in commercial distribution (GUDID) as of 23 Oct 2026.

Active United States. Also listed in GUDID (US), not in commercial distribution.

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K040855

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00888515041318 UDI-DI Date20 Sep 2018ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK040855 Date16 Apr 2004DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K040855 decided 16 Apr 2004 Active
  • FDA GUDID UDI-DI 00888515041318 listed 20 Sep 2018 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K040855
  2. Listed FDA GUDID 00888515041318

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Boss Instruments
Generic name
Surgical support tape, bioabsorbable
Model / Ref / Catalog
35-5167
Primary DI / UDI-DI
00888515041318
510(k) Number
FDA product code
GEI
GMDN term
Surgical support tape, bioabsorbable
Device class
Class II
Regulation number
878.4400
GUDID distribution status
Not in Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Cleared under the same submission (K040855)

and 8 more cleared under K040855

Similar devices

Other devices filed under FDA product code GEI (Electrosurgical, cutting & coagulation & accessories).

Other devices from Boss Instruments, Ltd.

See all devices from Boss Instruments, Ltd. →

Properties

  • Sterilise before use
  • Implantable
  • Prescription use
  • Lot / batch number
Other properties (11, all answered No)