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FDA 510(k)

DYNABITE HOT GI BIOPSY FORCEPS

K-Number: K970083 · 1997-06-17

ApplicantPortlyn Corp.
Decision Date1997-06-17
Product CodeKGE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DYNABITE HOT GI BIOPSY 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 1997-06-17 under 510(k) number K970083. The device is classified under product code KGE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DYNABITE HOT GI BIOPSY FORCEPS?

DYNABITE HOT GI BIOPSY FORCEPS is a medical device that received FDA 510(k) clearance on 1997-06-17. The listed applicant is Portlyn Corp.. The 510(k) number is K970083.

When did DYNABITE HOT GI BIOPSY FORCEPS receive FDA 510(k) clearance?

DYNABITE HOT GI BIOPSY FORCEPS received FDA 510(k) clearance on 1997-06-17, under 510(k) number K970083.

Who is the listed applicant for DYNABITE HOT GI BIOPSY 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 HOT GI BIOPSY FORCEPS?

The FDA product code for DYNABITE HOT GI BIOPSY FORCEPS is KGE.

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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.

K951447DYNABITE CARDIOVASCULAR BIOPSY FORCEPSK952391DYNABITE UROLOGICAL FORCEPSK944245DYNABITE LAPAROSCOPIC FORCEPSK934506DYNABITE HYSTEROSCOPIC FORCEPSK901300BIOPSY FORCEPSK896147BIOPSY FORCEP (NON-ELECTRIC)

View all 8 devices →

Related Devices (Code: KGE)

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.

K251807Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-411UR, FD-412LROlympus Medical Systems Corp.K250187Disposable Hot Biopsy Forceps (FD-210U); Disposable Hot Biopsy Forceps (FD-230U)Olympus Medical Systems CorporationK242857ClearHemograsperFinemedix Co., Ltd.K231721Disposable Hot Biopsy ForcepsBeijing Zksk Technology Co., Ltd.K220053Diathermic Slitter (FlushKnife) DK2620JI and DK2623JIFujifilm CorporationK210406Bipolar Coagulation ForecepsHangzhou AGS MedTech Co., Ltd.

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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