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Bio Protech Pro-Pencil SBH

by Bio Protech USA, Inc.

Bio Protech Pro-Pencil SBH is a Class II device made by Bio Protech USA, Inc., cleared under FDA 510(k) K092732 on 25 Nov 2009 and listed in FDA GUDID since 29 Jun 2016 (UDI-DI 00817120020241), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K092732

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00817120020241 UDI-DI Date29 Jun 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK092732 Date25 Nov 2009DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K092732 decided 25 Nov 2009 Active
  • FDA GUDID UDI-DI 00817120020241 listed 29 Jun 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K092732
  2. Listed FDA GUDID 00817120020241

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Bio Protech
Generic name
Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
Model / reference
Pro-Pencil SBH
Primary DI / UDI-DI
00817120020241
510(k) Number
FDA product code
GEI
GMDN term
Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
Device class
Class II
Regulation number
878.4400
GUDID distribution status
In Commercial Distribution

Related devices

Category: Open-surgery electrosurgical handpiece/electrode, monopolar, reusable

Cleared under the same submission (K092732)

and 8 more cleared under K092732

Similar devices in this category

Other devices filed under Open-surgery electrosurgical handpiece/electrode, monopolar, reusable.

Other devices from Bio Protech USA, Inc.

See all devices from Bio Protech USA, Inc. →

Properties

  • Supplied sterile
  • Prescription use
  • Lot / batch number
  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (9, all answered No)