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FDA 510(k)

SUTUREGROOVE

K-Number: K994289 · 2000-04-17

ApplicantIop, Inc.
Decision Date2000-04-17
Product CodeMML
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

SUTUREGROOVE is the device name listed in this FDA 510(k) record. The listed applicant is Iop, Inc.. It received FDA 510(k) clearance on 2000-04-17 under 510(k) number K994289. The device is classified under product code MML. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SUTUREGROOVE?

SUTUREGROOVE is a medical device that received FDA 510(k) clearance on 2000-04-17. The listed applicant is Iop, Inc.. The 510(k) number is K994289.

When did SUTUREGROOVE receive FDA 510(k) clearance?

SUTUREGROOVE received FDA 510(k) clearance on 2000-04-17, under 510(k) number K994289.

Who is the listed applicant for SUTUREGROOVE?

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

What is the FDA product code for SUTUREGROOVE?

The FDA product code for SUTUREGROOVE is MML.

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Other records listing Iop, 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.

K090078KERASYS BIOENGINEERED LAMELLAR PATCH GRAFTK062252MOLTENO3K053622SURGISIS OCULAR GRAFTK010852OSMED TISSUE EXPANDERK003646SUTUREGROOVE WEIGHT SIZING SETK972143MOA BONE / M-SPHERE

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Related Devices (Code: MML)

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.

K170591Altomed Malhotra Platinum SegmentsAltomed LimitedK021750LID CHAIN EYELID WEIGHTSJedmed Instrument Co.K011740CONTOUR DESIGN GOLD EYELID IMPLANT, MODEL CONTOUR DESIGN (SERIES 3000)Meddev Corp.K011115KURZ UPPER EYELID IMPLANT- PLATINUM/IRIDIUM,MODELS REGULAR 4007 003-007, SPECIAL 4007 002, 4007 008-010Heinz Kurz GmbH MedizintechnikK003646SUTUREGROOVE WEIGHT SIZING SETIop, Inc.K001123KURZ UPPER EYELID IMPLANT SIZERS, MODEL 8000 111Heinz Kurz GmbH Medizintechnik

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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