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FDA 510(k)

MODEL 8 & 20 ARGON LASER FOR PELVIC SURGERY IN GYN

K-Number: K862227 · 1986-08-19

ApplicantHgm, Inc.
Decision Date1986-08-19
Product CodeHHR
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

MODEL 8 & 20 ARGON LASER FOR PELVIC SURGERY IN GYN is the device name listed in this FDA 510(k) record. The listed applicant is Hgm, Inc.. It received FDA 510(k) clearance on 1986-08-19 under 510(k) number K862227. 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 MODEL 8 & 20 ARGON LASER FOR PELVIC SURGERY IN GYN?

MODEL 8 & 20 ARGON LASER FOR PELVIC SURGERY IN GYN is a medical device that received FDA 510(k) clearance on 1986-08-19. The listed applicant is Hgm, Inc.. The 510(k) number is K862227.

When did MODEL 8 & 20 ARGON LASER FOR PELVIC SURGERY IN GYN receive FDA 510(k) clearance?

MODEL 8 & 20 ARGON LASER FOR PELVIC SURGERY IN GYN received FDA 510(k) clearance on 1986-08-19, under 510(k) number K862227.

Who is the listed applicant for MODEL 8 & 20 ARGON LASER FOR PELVIC SURGERY IN GYN?

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

What is the FDA product code for MODEL 8 & 20 ARGON LASER FOR PELVIC SURGERY IN GYN?

The FDA product code for MODEL 8 & 20 ARGON LASER FOR PELVIC SURGERY IN GYN is HHR.

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Other records listing Hgm, 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.

K950120SMART PLUGK931072HGM ILLUMINATING/ASPIRATING ENDOOCULAR PROBEK931784HGM ILLUMINATING IMAGING ENDOCULAR PROBEK933333HGM SCANMAN PLUSK931499Q-11 OPHTHALMIC LASERK925663HGM ASPIRATING ENDOOCULAR(TM) PROBE

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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.

K881507ENDOCOAGULATOR MODEL 20 LASER & ACCESSORIESHgm Medical Laser Systems, Inc.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.

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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