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Healicoll

by Encoll Corp.

510(k) K040314

Healicoll is a device classified as Unclassified made by Encoll Corp., cleared under FDA 510(k) K040314 on 12 Aug 2004, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK040314 Date12 Aug 2004ClearedStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
KGN
Device class
U
Advisory committee
Unknown
FDA decision
SESE Substantially Equivalent

Devices cleared under K040314

9 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K040314
UDI-DISize and differences
HELICOLL HC0.5dia
Encoll Corp.
HC0.5dia / HC0.5dia10860000744444 —On the market
HELICOLL HC0.8x1.6
Encoll Corp.
HC0.8x1.6 / HC0.8x1.610860000744468 —On the market
HELICOLL HC1.0dia
Encoll Corp.
HC1.0dia / HC1.0dia10860000744451 —On the market
HELICOLL HC1.2x1.6
Encoll Corp.
HC1.2x1.6 / HC1.2x1.610860000744475 —On the market
HELICOLL HC1.6x1.6
Encoll Corp.
HC1.6x1.6 / HC1.6x1.610860000744482 —On the market
HELICOLL HC2x2
Encoll Corp.
HC2x2 / HC2x210860000744406 —On the market
HELICOLL HC2x4
Encoll Corp.
HC2x4 / HC2x410860000744413 —On the market
HELICOLL HC4x4
Encoll Corp.
HC4x4 / HC4x410860000744420 —On the market
HELICOLL HC8x8
Encoll Corp.
HC8x8 / HC8x810860000744437 —On the market

Similar devices

Other devices filed under FDA product code KGN (Wound Dressing With Animal-Derived Material(S)).

Other devices from Encoll Corp.

  • HELICOLL HC0.8x1.6

    Unclassified

  • HELICOLL HC4x4

    Unclassified

  • HELICOLL HC8x8

    Unclassified

  • HELICOLL HC0.5dia

    Unclassified

See all devices from Encoll Corp. →