Acufex Suture Retriever, Sterile Disposable

FDA 510(k) K881224 · Acufex Microsurgical, Inc.

Substantially Equivalent

510(k) numberK881224

Submission

Device name
Acufex Suture Retriever, Sterile Disposable
Applicant
Acufex Microsurgical, Inc.
Norwood, MA, US
Received
March 22, 1988
Decision date
June 1, 1988
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
GAE – Snare, Surgical
Device class
Class I (low risk)
Regulation
21 CFR 878.4800
Specialty
General, Plastic Surgery

Other 510(k)s with product code GAE

510(k)DeviceApplicantDecision
K950776Bipolar SnareGAE · Traditional Cook Urological, Inc.04/18/1995SE
K926036Acufex Suture RetrieverGAE · Traditional Acufex Microsurgical, Inc.05/05/1993SE
K903174Advance Suture Absorbable Gut SutureGAE · Traditional Advance Suture, Inc.07/10/1991SE

More from Advance Suture, Inc.

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K961555Acufex Tag Bioabsorbable AnchorsJDR · Traditional 07/10/1996SE
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K954246Acufex Endofix Absorbable Interference ScrewHWC · Traditional 02/15/1996SN
K952535Acufex Endobutton TapeGAT · Traditional 02/08/1996SN
K953276Acufex Tag Delivery SystemJDR · Traditional 10/05/1995SE
K953459Acufex Tag AnchorMBI · Traditional 08/23/1995SE
K941740Acufex Rotator Cuff Fixation ButtonKGS · Traditional 06/30/1995SE
K944500Acufex Patellar Bone Block SizerHRX · Traditional 06/12/1995SE
K951859Acufex Endobutton PackHRX · Traditional 06/09/1995SE
K946346Acufex Tag(R) Bioabsorbable AnchorsJDR · Traditional 04/26/1995SE

Questions and answers

When was Acufex Suture Retriever, Sterile Disposable cleared by the FDA?

Acufex Suture Retriever, Sterile Disposable (K881224) received a 510(k) decision of Substantially Equivalent on June 1, 1988, 71 days after the submission was received.

What is the product code of K881224?

The FDA product code is GAE – Snare, Surgical, a Class I (low risk) device regulated under 21 CFR 878.4800.