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Suprasorb P Sensitive Ag 10cm x 10cm with border

by L&R USA Inc.

Suprasorb P Sensitive Ag 10cm x 10cm with border (180011) is a device classified as Unclassified made by L&R USA Inc., cleared under FDA 510(k) K170077 on 30 Mar 2017 and listed in FDA GUDID since 15 Sep 2021 (UDI-DI 04063591428024), 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) K170077

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 Number04063591428024 UDI-DI Date15 Sep 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK170077 Date30 Mar 2017DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K170077 decided 30 Mar 2017 Active
  • FDA GUDID UDI-DI 04063591428024 listed 15 Sep 2021 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K170077
  2. Listed FDA GUDID 04063591428024

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Suprasorb P Sensitive Ag
Generic name
Wound-nonadherent dressing, absorbent, antimicrobial
Model / Ref / Catalog
10cm x 10cm with border, 180011
Primary DI / UDI-DI
04063591428024
510(k) Number
FDA product code
FRO
GMDN term
Wound-nonadherent dressing, absorbent, antimicrobial
Device class
U
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code FRO (Dressing, Wound, Drug).

Other devices from L&R USA Inc.

See all devices from L&R USA Inc. →

Properties

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