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FDA 510(k)

E-Pack Procedure Kit

K-Number: K161726 · 2016-07-12

ApplicantETHICON, Inc.
Decision Date2016-07-12
Product CodeGAM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

E-Pack Procedure Kit is the device name listed in this FDA 510(k) record. The listed applicant is ETHICON, Inc.. It received FDA 510(k) clearance on 2016-07-12 under 510(k) number K161726. The device is classified under product code GAM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the E-Pack Procedure Kit?

E-Pack Procedure Kit is a medical device that received FDA 510(k) clearance on 2016-07-12. The listed applicant is ETHICON, Inc.. The 510(k) number is K161726.

When did E-Pack Procedure Kit receive FDA 510(k) clearance?

E-Pack Procedure Kit received FDA 510(k) clearance on 2016-07-12, under 510(k) number K161726.

Who is the listed applicant for E-Pack Procedure Kit?

The FDA 510(k) record lists ETHICON, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for E-Pack Procedure Kit?

The FDA product code for E-Pack Procedure Kit is GAM.

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Other records listing ETHICON, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

PMA N12159Agent, absorbable hemostatic, non-collagen basedPMA P880047Barrier, absorbable, adhesionPMA P240035Agent, absorbable hemostatic, collagen with polymeric additivesK253394Coated VICRYL™ (Polyglactin 910) Plus Antibacterial SutureK252047STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control DevicesK253572STRATAFIX™ Spiral PRONOVA™ Unidirectional Knotless Tissue Control Device STRATAFIX™ Spiral PRONOVA™ Bidirectional Knotless Tissue Control Device

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Related Devices (Code: GAM)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253394Coated VICRYL™ (Polyglactin 910) Plus Antibacterial SutureETHICON, Inc.K253530Trexon™ Monofilament Synthetic Absorbable SutureMedtronicK253852MONOCRYL™ Plus Antibacterial Poliglecaprone – 25 (Monofilament), Sterile Synthetic Absorbable Surgical SutureETHICON, Inc.K252743STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device; STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control DeviceETHICON, Inc.K253620TroClose 1200Gordian Surgical, Ltd.K252820PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Calypso); PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Odysseus)Internacional Farmacéutica S.A DE C.V

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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