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PUMA-G Pediatric System™ 0010380

by Coaptech, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850026037203 UDI-DI Date23 Dec 2025ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
PUMA-G Pediatric System™
Generic Name
Ultrasound-guided gastrostomy system catheter
Model / Ref / Catalog
0010380, 0010381
Description
Percutaneous Ultrasound Gastrostomy (PUG) System Essentials Kit
Primary DI / UDI-DI
00850026037203
510(k) Number
FDA Product Code
KGC
GMDN Term
Ultrasound-guided gastrostomy system catheter
Device Class
Class II
Regulation Number
876.5980
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K242211)

Other devices from Coaptech, Inc.

See all devices from Coaptech, Inc. →

Properties

  • Single Use
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date

Other properties (9)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No