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FDA 510(k)

DYNABITE HYSTEROSCOPIC FORCEPS

K-Number: K934506 · 1994-03-22

ApplicantPortlyn Corp.
Decision Date1994-03-22
Product CodeHET
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

DYNABITE HYSTEROSCOPIC FORCEPS is the device name listed in this FDA 510(k) record. The listed applicant is Portlyn Corp.. It received FDA 510(k) clearance on 1994-03-22 under 510(k) number K934506. The device is classified under product code HET. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DYNABITE HYSTEROSCOPIC FORCEPS?

DYNABITE HYSTEROSCOPIC FORCEPS is a medical device that received FDA 510(k) clearance on 1994-03-22. The listed applicant is Portlyn Corp.. The 510(k) number is K934506.

When did DYNABITE HYSTEROSCOPIC FORCEPS receive FDA 510(k) clearance?

DYNABITE HYSTEROSCOPIC FORCEPS received FDA 510(k) clearance on 1994-03-22, under 510(k) number K934506.

Who is the listed applicant for DYNABITE HYSTEROSCOPIC FORCEPS?

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

What is the FDA product code for DYNABITE HYSTEROSCOPIC FORCEPS?

The FDA product code for DYNABITE HYSTEROSCOPIC FORCEPS is HET.

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Other records listing Portlyn Corp. 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.

K970083DYNABITE HOT GI BIOPSY FORCEPSK951447DYNABITE CARDIOVASCULAR BIOPSY FORCEPSK952391DYNABITE UROLOGICAL FORCEPSK944245DYNABITE LAPAROSCOPIC FORCEPSK901300BIOPSY FORCEPSK896147BIOPSY FORCEP (NON-ELECTRIC)

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Related Devices (Code: HET)

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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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