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FDA 510(k)

CRYSTONA

K-Number: K811754 · 1981-07-20

ApplicantSmith & Nephew, Inc.
Decision Date1981-07-20
Product CodeITG
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

CRYSTONA is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew, Inc.. It received FDA 510(k) clearance on 1981-07-20 under 510(k) number K811754. The device is classified under product code ITG. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CRYSTONA?

CRYSTONA is a medical device that received FDA 510(k) clearance on 1981-07-20. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K811754.

When did CRYSTONA receive FDA 510(k) clearance?

CRYSTONA received FDA 510(k) clearance on 1981-07-20, under 510(k) number K811754.

Who is the listed applicant for CRYSTONA?

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

What is the FDA product code for CRYSTONA?

The FDA product code for CRYSTONA is ITG.

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Related Devices (Code: ITG)

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.

K873111CONFORMA(TM) PLASTER BANDAGESThe Kendal Co.K862115DEKNA BAND KITDeknatel, Inc.K842573T.P.G. CAST TAPEThe Poly Group, Inc.K840416HEXCELITEHexcel MedicalK833732NON WETTING UNDERCAST PADDINGAmerican Medical Disposable, Inc.K832992SOFFBAN ORTHOPEDIC PADDINGSmith & Nephew, 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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