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FDA 510(k)

DILKES LASER/SUCTION CANNULAE

K-Number: K981143 · 1998-09-14

ApplicantExmoor Plastics , Ltd.
Decision Date1998-09-14
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DILKES LASER/SUCTION CANNULAE is the device name listed in this FDA 510(k) record. The listed applicant is Exmoor Plastics , Ltd.. It received FDA 510(k) clearance on 1998-09-14 under 510(k) number K981143. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DILKES LASER/SUCTION CANNULAE?

DILKES LASER/SUCTION CANNULAE is a medical device that received FDA 510(k) clearance on 1998-09-14. The listed applicant is Exmoor Plastics , Ltd.. The 510(k) number is K981143.

When did DILKES LASER/SUCTION CANNULAE receive FDA 510(k) clearance?

DILKES LASER/SUCTION CANNULAE received FDA 510(k) clearance on 1998-09-14, under 510(k) number K981143.

Who is the listed applicant for DILKES LASER/SUCTION CANNULAE?

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

What is the FDA product code for DILKES LASER/SUCTION CANNULAE?

The FDA product code for DILKES LASER/SUCTION CANNULAE is GEX. This falls under the Gastroenterology category.

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Other records listing Exmoor Plastics , Ltd. 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.

K093863EPIDRUMK990366EXMOOR SUCTION CLEARANCE KITK980828EXMOOR MYRINGOTOMY KITK972700EXMOOR ATTIC AND MASTOID ANTRUM MIDDLE EAR IMPLANT (EMMETT CAMPBELL MD FACS PATTERN)K981088MILLS COLUMELLA PROSTHESISK981045EXMOOR TEFLON LOOP REPLACEMENT PROSTHESIS

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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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