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FDA 510(k)

ADAPTAIN, ADAPTAIN FASTWRAP, ENVELOCK, BIOWAI

K-Number: K132198 · 2013-09-12

ApplicantCeremed , Inc.
Decision Date2013-09-12
Product CodeKHJ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

ADAPTAIN, ADAPTAIN FASTWRAP, ENVELOCK, BIOWAI is the device name listed in this FDA 510(k) record. The listed applicant is Ceremed , Inc.. It received FDA 510(k) clearance on 2013-09-12 under 510(k) number K132198. The device is classified under product code KHJ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADAPTAIN, ADAPTAIN FASTWRAP, ENVELOCK, BIOWAI?

ADAPTAIN, ADAPTAIN FASTWRAP, ENVELOCK, BIOWAI is a medical device that received FDA 510(k) clearance on 2013-09-12. The listed applicant is Ceremed , Inc.. The 510(k) number is K132198.

When did ADAPTAIN, ADAPTAIN FASTWRAP, ENVELOCK, BIOWAI receive FDA 510(k) clearance?

ADAPTAIN, ADAPTAIN FASTWRAP, ENVELOCK, BIOWAI received FDA 510(k) clearance on 2013-09-12, under 510(k) number K132198.

Who is the listed applicant for ADAPTAIN, ADAPTAIN FASTWRAP, ENVELOCK, BIOWAI?

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

What is the FDA product code for ADAPTAIN, ADAPTAIN FASTWRAP, ENVELOCK, BIOWAI?

The FDA product code for ADAPTAIN, ADAPTAIN FASTWRAP, ENVELOCK, BIOWAI is KHJ.

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Other records listing Ceremed , 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.

K161446Biopor Porous Polyethylene ImplantsK160988Biopor, AOC Porous Polyethylene, CereporK122561ADAPTAIN FASTWRAP, ENVELOCK, GRAFTAINK120220ADAPTAIN SOLUBLE IMPLANT MATERIALK103047CERETENE SOLUBLE IMPLANT MATERIALK102071OSTENE CT, AOC CT, OSTEOTENE, CERETENE

View all 19 devices →

Related Devices (Code: KHJ)

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.

K260266Tympendi™ (810)Grace Medical, Inc.K232646Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.6-0.9)Cook Biotech IncorporatedK161000Biodesign Otologic Repair GraftCook Biotech IncorporatedK121360BIODESIGN ENT REPAIR GRAFTCook Biotech IncorpratedK122561ADAPTAIN FASTWRAP, ENVELOCK, GRAFTAINCeremed , Inc.K120220ADAPTAIN SOLUBLE IMPLANT MATERIALCeremed , Inc.

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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