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FDA 510(k)

ENDOCOAGULATOR MODEL 20 LASER & ACCESSORIES

K-Number: K881507 · 1989-04-27

ApplicantHgm Medical Laser Systems, Inc.
Decision Date1989-04-27
Product CodeHHR
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

ENDOCOAGULATOR MODEL 20 LASER & ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is Hgm Medical Laser Systems, Inc.. It received FDA 510(k) clearance on 1989-04-27 under 510(k) number K881507. The device is classified under product code HHR. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDOCOAGULATOR MODEL 20 LASER & ACCESSORIES?

ENDOCOAGULATOR MODEL 20 LASER & ACCESSORIES is a medical device that received FDA 510(k) clearance on 1989-04-27. The listed applicant is Hgm Medical Laser Systems, Inc.. The 510(k) number is K881507.

When did ENDOCOAGULATOR MODEL 20 LASER & ACCESSORIES receive FDA 510(k) clearance?

ENDOCOAGULATOR MODEL 20 LASER & ACCESSORIES received FDA 510(k) clearance on 1989-04-27, under 510(k) number K881507.

Who is the listed applicant for ENDOCOAGULATOR MODEL 20 LASER & ACCESSORIES?

The FDA 510(k) record lists Hgm Medical Laser Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ENDOCOAGULATOR MODEL 20 LASER & ACCESSORIES?

The FDA product code for ENDOCOAGULATOR MODEL 20 LASER & ACCESSORIES is HHR.

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Other records listing Hgm Medical Laser Systems, Inc. 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.

K921300MODEL PC ARGON ION LASERK914484LITESPOT(TM) LASER INDIRECT OPHTHALMOSCOPEK913569COMPAC A, ELITE A, ELITE A PLUS, SURGICA AK912628AIR ARGON ION LASERS VARIOUS MODELSK910272HGM COMBINATION ND:YAG & SOLID STATE GREENK912438MODELS 5,8,20,20S ARGON ION LASERS

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Related Devices (Code: HHR)

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.

K871875MODEL 5050 SURGILASER FOR OB-GYN USELasermatic, Inc.K875314GL-35 COLPOSCOPIC LASER SYSTEMLaser Engineering, Inc.K874615LASER CANNISTER FILTERMedical Marketing, Inc.K880591LASEGUIDE 600A, 600B, 400A, 400B FOR OB-GYN USELaser Peripherals, LLCK880930MDLS 4000,4900,6000,8000,8900 ND:YAG/1700 C02 LASECopper Lasersonics, Inc.K880991LASER OPTICAL CATHETER SYSTEMMedline Industries, 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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