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V7 G, jar 1PC

by Hersill Sl

V7 G, jar 1PC (5320271) is an emergency airway clearance suction system (FDA Class II; FDA product code BTA, Pump, Portable, Aspiration (Manual Or Powered)) made by Hersill Sl, cleared under FDA 510(k) K093241 on 27 Apr 2010 and listed in FDA GUDID since 31 Jan 2018 (UDI-DI 08435331739619), active as of 23 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 23 Oct 2026

Documents

510(k) K093241

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 Number08435331739619 UDI-DI Date31 Jan 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK093241 Date27 Apr 2010DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K093241 decided 27 Apr 2010 Active
  • FDA GUDID UDI-DI 08435331739619 listed 31 Jan 2018 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K093241
  2. Listed FDA GUDID 08435331739619

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
V7
Generic name
Emergency airway clearance suction system, electric
Model / Ref / Catalog
V7 G, jar 1PC, 5320271
Primary DI / UDI-DI
08435331739619
510(k) Number
FDA product code
BTA
GMDN term
Emergency airway clearance suction system, electric
Device class
Class II
Regulation number
878.4780
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code BTA (Pump, Portable, Aspiration (Manual Or Powered)).

Other devices from Hersill Sl

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Properties

  • Prescription use
  • Lot / batch number
Other properties (13, all answered No)