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Snap™ SNPA075US

by Kci USA, Inc.

Snap™ SNPA075US is a Class II device made by Kci USA, Inc., cleared under FDA 510(k) K112341 on 29 Aug 2011 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00849554006034), 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) K112341

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 Number00849554006034 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK112341 Date29 Aug 2011DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K112341 decided 29 Aug 2011 Active
  • FDA GUDID UDI-DI 00849554006034 listed 24 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K112341
  2. Listed FDA GUDID 00849554006034

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Snap™
Generic name
Negative-pressure wound therapy system pump, mechanical
Model / reference
SNPA075US
Primary DI / UDI-DI
00849554006034
510(k) Number
FDA product code
OKO
GMDN term
Negative-pressure wound therapy system pump, mechanical
Device class
Class II
Regulation number
878.4683
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Similar devices

Other devices filed under FDA product code OKO (Negative Pressure Wound Therapy Non-Powered Suction Apparatus).

Other devices from Kci USA, Inc.

See all devices from Kci USA, Inc. →

Properties

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