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FDA 510(k)

DISPOSABLE LAPAROSCOPIC INSTRUMENT

K-Number: K070812 · 2007-09-14

ApplicantModern Medical Equipment Mfg., Ltd.
Decision Date2007-09-14
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE LAPAROSCOPIC INSTRUMENT is the device name listed in this FDA 510(k) record. The listed applicant is Modern Medical Equipment Mfg., Ltd.. It received FDA 510(k) clearance on 2007-09-14 under 510(k) number K070812. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DISPOSABLE LAPAROSCOPIC INSTRUMENT?

DISPOSABLE LAPAROSCOPIC INSTRUMENT is a medical device that received FDA 510(k) clearance on 2007-09-14. The listed applicant is Modern Medical Equipment Mfg., Ltd.. The 510(k) number is K070812.

When did DISPOSABLE LAPAROSCOPIC INSTRUMENT receive FDA 510(k) clearance?

DISPOSABLE LAPAROSCOPIC INSTRUMENT received FDA 510(k) clearance on 2007-09-14, under 510(k) number K070812.

Who is the listed applicant for DISPOSABLE LAPAROSCOPIC INSTRUMENT?

The FDA 510(k) record lists Modern Medical Equipment Mfg., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DISPOSABLE LAPAROSCOPIC INSTRUMENT?

The FDA product code for DISPOSABLE LAPAROSCOPIC INSTRUMENT is GEI.

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Other records listing Modern Medical Equipment Mfg., 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.

K093479DISPOSABLE SUCTION AND IRRIGATION SYSTEMK091511MODERN MEDICAL RESECTOSCOPE ELECTRODESK070877ENDOCERVICAL ELECTRODE # 2K050842AGCEL WOUND DRESSING,AGCEL BURN DRESSINGK043036NON-STICK ELECTRODEK033095SMOKE EVACUATION ATTACHEMENT

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Related Devices (Code: GEI)

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.

K261959Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch (0703-046-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Push Button Switch, Bulk Non-Sterile (0703-046-102);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Rocker Switch (0703-047-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Rocker Switch, Bulk Non-Sterile (0703-047-102)Stryker InstrumentsK254196HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)Ethicon Endo-Surgery, LLCK261070LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider, Nano-coatedCovidien, LLCK254185Potenza PrimeJeisys Medical IncorporatedK262364Ellian Enigma RF DeviceEllian CorpK253859Scarlet Pro (Scarlet Pro)VIOL 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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