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)

UNSTERILIZED LAPAROTOMY SPONGES (CHINA)

K-Number: K811632 · 1981-09-11

ApplicantRobert I. Chien & Assoc., Inc.
Decision Date1981-09-11
Product CodeGDY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

UNSTERILIZED LAPAROTOMY SPONGES (CHINA) is the device name listed in this FDA 510(k) record. The listed applicant is Robert I. Chien & Assoc., Inc.. It received FDA 510(k) clearance on 1981-09-11 under 510(k) number K811632. The device is classified under product code GDY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNSTERILIZED LAPAROTOMY SPONGES (CHINA)?

UNSTERILIZED LAPAROTOMY SPONGES (CHINA) is a medical device that received FDA 510(k) clearance on 1981-09-11. The listed applicant is Robert I. Chien & Assoc., Inc.. The 510(k) number is K811632.

When did UNSTERILIZED LAPAROTOMY SPONGES (CHINA) receive FDA 510(k) clearance?

UNSTERILIZED LAPAROTOMY SPONGES (CHINA) received FDA 510(k) clearance on 1981-09-11, under 510(k) number K811632.

Who is the listed applicant for UNSTERILIZED LAPAROTOMY SPONGES (CHINA)?

The FDA 510(k) record lists Robert I. Chien & Assoc., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UNSTERILIZED LAPAROTOMY SPONGES (CHINA)?

The FDA product code for UNSTERILIZED LAPAROTOMY SPONGES (CHINA) is GDY.

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 Robert I. Chien & Assoc., 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.

K822151SURGICAL INSTRUMENTS REPRESENT. 4 CLASSK811631THERMOMETER (MADE IN CHINA)K810054RICA (DIAGNOSTIC INSTRUMENTS)K801819SURGICAL INSTRUMENTSK801028RICA OR SMIC SURGICAL INSTRUMENTS

Related Devices (Code: GDY)

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.

K972634ULTRACELL SUCTION SPONGEUltracell Medical Technologies, Inc.K960236CPR LAP SPONGESCustom Pack ReliabilityK955599STRYKER FEMORAL CANAL SPONGE & ACETABULUM SPONGEStryker Corp.K955322PROTEC X-RAY DETECTABLE GAUZE SPONGEDerivados DE Gasa, S.A. DE C.V.K953830KENSORBKentron Health Care, Inc.K953059KITTNER DISSECTORMedical Perspectives 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.

↑