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FDA 510(k)

SILASTIC TENDON PASSER H.P.

K-Number: K811679 · 1981-07-10

ApplicantDow Corning Corp. Healthcare Industries Materials
Decision Date1981-07-10
Product CodeHWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SILASTIC TENDON PASSER H.P. is the device name listed in this FDA 510(k) record. The listed applicant is Dow Corning Corp. Healthcare Industries Materials. It received FDA 510(k) clearance on 1981-07-10 under 510(k) number K811679. The device is classified under product code HWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SILASTIC TENDON PASSER H.P.?

SILASTIC TENDON PASSER H.P. is a medical device that received FDA 510(k) clearance on 1981-07-10. The listed applicant is Dow Corning Corp. Healthcare Industries Materials. The 510(k) number is K811679.

When did SILASTIC TENDON PASSER H.P. receive FDA 510(k) clearance?

SILASTIC TENDON PASSER H.P. received FDA 510(k) clearance on 1981-07-10, under 510(k) number K811679.

Who is the listed applicant for SILASTIC TENDON PASSER H.P.?

The FDA 510(k) record lists Dow Corning Corp. Healthcare Industries Materials as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SILASTIC TENDON PASSER H.P.?

The FDA product code for SILASTIC TENDON PASSER H.P. is HWQ.

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Other records listing Dow Corning Corp. Healthcare Industries Materials 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.

K853186SILASTIC INFLATABLE BONE PLUG H.P.K844637WHITESIDE ACRYLIC CEMENT SPACER SLEEVEK850255DOW CORNING WRIGHT TITANIUM WRIST JOINT GROMMETK843995TF-II HIP PROSTHESISK842559WHITESIDE ORTHOLOC TOTAL HIP FEMORALK840357SSA HIP PROSTHESIS

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Related Devices (Code: HWQ)

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.

K970360MITEK SUTURE RETROGRADERMitek ProductsK920621ACUFEX PASSING PINS AND SURGICAL WIREAcufex Microsurgical, Inc.K923381SOFT TISSUE EXPANDERAcufex Microsurgical, Inc.K885311MENISCUS MENDER II LOOPInstrument Makar, Inc.K843592VICO MICRO SURGICAL INSTRUMENTSVisitec Co.K841622SOFT-TISSUE INSTRUMENTPlastafil, 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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