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FDA 510(k)

SURGICAL CARBON DIOXIDE SYS. MODEL 10-C OB-GYN USE

K-Number: K862861 · 1986-10-27

ApplicantDirected Energy, Inc.
Decision Date1986-10-27
Product CodeHHR
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

SURGICAL CARBON DIOXIDE SYS. MODEL 10-C OB-GYN USE is the device name listed in this FDA 510(k) record. The listed applicant is Directed Energy, Inc.. It received FDA 510(k) clearance on 1986-10-27 under 510(k) number K862861. 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 SURGICAL CARBON DIOXIDE SYS. MODEL 10-C OB-GYN USE?

SURGICAL CARBON DIOXIDE SYS. MODEL 10-C OB-GYN USE is a medical device that received FDA 510(k) clearance on 1986-10-27. The listed applicant is Directed Energy, Inc.. The 510(k) number is K862861.

When did SURGICAL CARBON DIOXIDE SYS. MODEL 10-C OB-GYN USE receive FDA 510(k) clearance?

SURGICAL CARBON DIOXIDE SYS. MODEL 10-C OB-GYN USE received FDA 510(k) clearance on 1986-10-27, under 510(k) number K862861.

Who is the listed applicant for SURGICAL CARBON DIOXIDE SYS. MODEL 10-C OB-GYN USE?

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

What is the FDA product code for SURGICAL CARBON DIOXIDE SYS. MODEL 10-C OB-GYN USE?

The FDA product code for SURGICAL CARBON DIOXIDE SYS. MODEL 10-C OB-GYN USE is HHR.

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Other records listing Directed Energy, Inc. as applicant

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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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