FDA 510(k)

POSI-GRIP UMBILICAL CORD CLAMP, STERILE, MODEL 384, POSI-GRIP UMBILICAL CORD CLAMP, NON-STERILE, MODEL 385

K-Number: K010835 · 2001-04-30

ApplicantBusse Hospital Disposables, Inc.

Decision Date2001-04-30

Product CodeHFW

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

POSI-GRIP UMBILICAL CORD CLAMP, STERILE, MODEL 384, POSI-GRIP UMBILICAL CORD CLAMP, NON-STERILE, MODEL 385 is the device name listed in this FDA 510(k) record. The listed applicant is Busse Hospital Disposables, Inc.. It received FDA 510(k) clearance on 2001-04-30 under 510(k) number K010835. The device is classified under product code HFW. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POSI-GRIP UMBILICAL CORD CLAMP, STERILE, MODEL 384, POSI-GRIP UMBILICAL CORD CLAMP, NON-STERILE, MODEL 385?

POSI-GRIP UMBILICAL CORD CLAMP, STERILE, MODEL 384, POSI-GRIP UMBILICAL CORD CLAMP, NON-STERILE, MODEL 385 is a medical device that received FDA 510(k) clearance on 2001-04-30. The listed applicant is Busse Hospital Disposables, Inc.. The 510(k) number is K010835.

When did POSI-GRIP UMBILICAL CORD CLAMP, STERILE, MODEL 384, POSI-GRIP UMBILICAL CORD CLAMP, NON-STERILE, MODEL 385 receive FDA 510(k) clearance?

POSI-GRIP UMBILICAL CORD CLAMP, STERILE, MODEL 384, POSI-GRIP UMBILICAL CORD CLAMP, NON-STERILE, MODEL 385 received FDA 510(k) clearance on 2001-04-30, under 510(k) number K010835.

Who is the listed applicant for POSI-GRIP UMBILICAL CORD CLAMP, STERILE, MODEL 384, POSI-GRIP UMBILICAL CORD CLAMP, NON-STERILE, MODEL 385?

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

What is the FDA product code for POSI-GRIP UMBILICAL CORD CLAMP, STERILE, MODEL 384, POSI-GRIP UMBILICAL CORD CLAMP, NON-STERILE, MODEL 385?

The FDA product code for POSI-GRIP UMBILICAL CORD CLAMP, STERILE, MODEL 384, POSI-GRIP UMBILICAL CORD CLAMP, NON-STERILE, MODEL 385 is HFW.

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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Busse Hospital Disposables, Inc. as applicant

K120002I-STYLE BONE MARROW ASPIRATION NEEDLE WITH T-HANDLE K093909BUSSE SURGICAL DRAPES IV K092212BUSSE SURGICAL DRAPES III K082297BUSSE SURGICAL DRAPE K073222MODIFICATION TO:SPECIALTY NEEDLES K070465BUSSE EPIDURAL CATHETER

View all 31 devices →

Related Devices (Code: HFW)

K041332JOEY CLAMP OPENING TOOLMaternus, Inc.K033846KAEN YIH UMBILICAL CORD CLAMPKaen Yih Enterprise Co., Ltd.K020718SECURLINE UMBILICAL CORD CLAMP #3505 STERILE #3515 NON-STERILEPrecision Dynamics Corp.K021055BUSSE UMBILICAL CORD CLAMP CUTTERBusse Hospital Disposables, Inc.K012917DYNAREX UMBILICAL CORD LAMP, MODELS 6833 AND 6833-BDynarex Corp.K011621KOALA CLAMP, KOALA CLAMP AND CUTTERMaternus, 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.