Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SD-200IEHL(TM)

K-Number: K914517 · 1992-06-30

ApplicantNorthgate Technologies, Inc.
Decision Date1992-06-30
Product CodeFFK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SD-200IEHL(TM) is the device name listed in this FDA 510(k) record. The listed applicant is Northgate Technologies, Inc.. It received FDA 510(k) clearance on 1992-06-30 under 510(k) number K914517. The device is classified under product code FFK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SD-200IEHL(TM)?

SD-200IEHL(TM) is a medical device that received FDA 510(k) clearance on 1992-06-30. The listed applicant is Northgate Technologies, Inc.. The 510(k) number is K914517.

When did SD-200IEHL(TM) receive FDA 510(k) clearance?

SD-200IEHL(TM) received FDA 510(k) clearance on 1992-06-30, under 510(k) number K914517.

Who is the listed applicant for SD-200IEHL(TM)?

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

What is the FDA product code for SD-200IEHL(TM)?

The FDA product code for SD-200IEHL(TM) is FFK.

Other records listing Northgate Technologies, 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.

K202813URO-TOUCH 9 French ProbeK202944NEBULAE SRS Laparoscopic Surgical Smoke Removal SystemK130368AUTOLITH TOUCH; URO TOUCHK120151NEBULAE IK041560FLO-ASSISTANTK033614MISTIC HUMIDIFICATION SYSTEM 850-00/01/02, 2215

View all 55 devices →

Related Devices (Code: FFK)

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.

K242888Electrohydraulic Lithotriptor (TCS-B3-II)Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.K243032EHL Probe (SCDG-AS); EHL Probe (SCDG-BS); EHL Probe (SCDG-CS)Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.K230488EL27-Compact; Sterile EHL-ProbesWalz Elektronik GmbHK202813URO-TOUCH 9 French ProbeNorthgate Technologies, Inc.K191124Swiss LithoClast TrilogyE.M.S Electro Medical Systems S.AK162119UreTron PF Series ProbeMed-Sonics Corp.

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.

↑