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PosiSep C 9210754

by Hemostasis, LLC

PosiSep C 9210754 is a Class I device made by Hemostasis, LLC, cleared under FDA 510(k) K122494 on 27 Mar 2013 and listed in FDA GUDID since 20 Feb 2020 (UDI-DI 00858439001385), 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) K122494

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 Number00858439001385 UDI-DI Date20 Feb 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK122494 Date27 Mar 2013DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K122494 decided 27 Mar 2013 Active
  • FDA GUDID UDI-DI 00858439001385 listed 20 Feb 2020 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K122494
  2. Listed FDA GUDID 00858439001385

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
PosiSep C
Generic name
Chitosan haemostatic agent, professional, non-bioabsorbable
Model / reference
9210754
Primary DI / UDI-DI
00858439001385
510(k) Number
FDA product code
EMX, LYA
GMDN term
Chitosan haemostatic agent, professional, non-bioabsorbable
Device class
Class I
Regulation number
874.4100, 874.4780
GUDID distribution status
In Commercial Distribution
Size
Width — 1.27 Centimeter
Length — 3.81 Centimeter

Related devices

Category: Chitosan haemostatic agent, professional, non-bioabsorbableIntranasal splint, non-bioabsorbable, animal-derived

Cleared under the same submission (K122494)

and 5 more cleared under K122494

Similar devices

Other devices filed under FDA product code EMX (Balloon, Epistaxis).

Other devices from Hemostasis, LLC

See all devices from Hemostasis, LLC →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)