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)

LWEET CONE BIOPSY INSTRUMENT

K-Number: K961460 · 1996-11-19

ApplicantApple Medical Corp.
Decision Date1996-11-19
Product CodeHGI
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

LWEET CONE BIOPSY INSTRUMENT is the device name listed in this FDA 510(k) record. The listed applicant is Apple Medical Corp.. It received FDA 510(k) clearance on 1996-11-19 under 510(k) number K961460. The device is classified under product code HGI. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LWEET CONE BIOPSY INSTRUMENT?

LWEET CONE BIOPSY INSTRUMENT is a medical device that received FDA 510(k) clearance on 1996-11-19. The listed applicant is Apple Medical Corp.. The 510(k) number is K961460.

When did LWEET CONE BIOPSY INSTRUMENT receive FDA 510(k) clearance?

LWEET CONE BIOPSY INSTRUMENT received FDA 510(k) clearance on 1996-11-19, under 510(k) number K961460.

Who is the listed applicant for LWEET CONE BIOPSY INSTRUMENT?

The FDA 510(k) record lists Apple Medical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LWEET CONE BIOPSY INSTRUMENT?

The FDA product code for LWEET CONE BIOPSY INSTRUMENT is HGI.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Apple Medical Corp. 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.

K061651FISCHER CONE BIOPSY EXCISOR, MODELS 900-150, 151, 152, 154, 155, 157 AND 158K050256APPLE MEDICAL/OB MOBIUS ELASTIC RETRACTORK041131APPLE MEDICAL OB MOBIUS ELASTIC RETRACTORK014005APPLE MEDICAL MOBIUS ELASTIC RETRACTORK000026APPLE MEDICAL ONE-TOUCH UTERINE SAMPLERK970788PNEUMO-MATIC INSUFFLATION NEEDLE

View all 9 devices →

Related Devices (Code: HGI)

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.

K202915IRIS Thermocoagulator and Digital ColposcopeLiger Medical, LLCK152843Liger Medical HTU-110Liger Medical, LLCK121881DOMAIN SURGICAL SYSTEMDomain Surgical, Inc.K070877ENDOCERVICAL ELECTRODE # 2Modern Medical Equipment Mfg., Ltd.K061651FISCHER CONE BIOPSY EXCISOR, MODELS 900-150, 151, 152, 154, 155, 157 AND 158Apple Medical Corp.K022593THOMAS MEDICAL ELECTRODESThomas Medical, 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.

↑