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Dynamic DIAGNOSTICS, INC PEN11NS

by Bioprotech Inc.

Dynamic DIAGNOSTICS, INC PEN11NS is a Class II device made by Bioprotech Inc., cleared under FDA 510(k) K092732 on 25 Nov 2009 and listed in FDA GUDID since 12 Mar 2025 (UDI-DI 00851255007050), 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 Number00851255007050 UDI-DI Date12 Mar 2025ListedStatusListed 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 00851255007050 listed 12 Mar 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K092732
  2. Listed FDA GUDID 00851255007050

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Dynamic DIAGNOSTICS, INC
Generic name
Open-surgery electrosurgical handpiece/electrode, monopolar, single-use
Model / reference
PEN11NS
Primary DI / UDI-DI
00851255007050
510(k) Number
FDA product code
GEI
GMDN term
Open-surgery electrosurgical handpiece/electrode, monopolar, single-use
Device class
Class II
Regulation number
878.4400
GUDID distribution status
In Commercial Distribution

Related devices

Category: Open-surgery electrosurgical handpiece/electrode, monopolar, single-use

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, single-use.

Other devices from Bioprotech Inc.

See all devices from Bioprotech Inc. →

Properties

  • Single use
  • Contains latex
  • Prescription use
  • Lot / batch number
Other properties (11, all answered No)