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FDA 510(k)

BABYLANCE HEEL INCISION DEVICE , MODELS BLP50, BLP200, BLN50, BLN200

K-Number: K101417 · 2010-10-19

ApplicantMedipurpose Pte. , Ltd.
Decision Date2010-10-19
Product CodeFMK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BABYLANCE HEEL INCISION DEVICE , MODELS BLP50, BLP200, BLN50, BLN200 is the device name listed in this FDA 510(k) record. The listed applicant is Medipurpose Pte. , Ltd.. It received FDA 510(k) clearance on 2010-10-19 under 510(k) number K101417. The device is classified under product code FMK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BABYLANCE HEEL INCISION DEVICE , MODELS BLP50, BLP200, BLN50, BLN200?

BABYLANCE HEEL INCISION DEVICE , MODELS BLP50, BLP200, BLN50, BLN200 is a medical device that received FDA 510(k) clearance on 2010-10-19. The listed applicant is Medipurpose Pte. , Ltd.. The 510(k) number is K101417.

When did BABYLANCE HEEL INCISION DEVICE , MODELS BLP50, BLP200, BLN50, BLN200 receive FDA 510(k) clearance?

BABYLANCE HEEL INCISION DEVICE , MODELS BLP50, BLP200, BLN50, BLN200 received FDA 510(k) clearance on 2010-10-19, under 510(k) number K101417.

Who is the listed applicant for BABYLANCE HEEL INCISION DEVICE , MODELS BLP50, BLP200, BLN50, BLN200?

The FDA 510(k) record lists Medipurpose Pte. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BABYLANCE HEEL INCISION DEVICE , MODELS BLP50, BLP200, BLN50, BLN200?

The FDA product code for BABYLANCE HEEL INCISION DEVICE , MODELS BLP50, BLP200, BLN50, BLN200 is FMK.

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 Medipurpose Pte. , Ltd. 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.

K222224SurgiLance® Safety LancetK130132BABYLANCE HEEL INCISION DEVICEK110062MEDIPLUS-FOAM AG; MEDIPLUS-COMFORTFOAM AG; MEDIPLUS-SUPERFOAM AGK101145SURGILANCE SAFETY LANCETS, MODELS SLN100, SLN200, SLN240, SLN300, SLB200, SLB250

Related Devices (Code: FMK)

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.

K262526Safety lancet (XL)Tianjin Huahong Technology Co., Ltd.K261045Verifine Safety LancetsPromisemed Hangzhou Meditech Co., Ltd.K260191Safety lancet (XXXVII)Tianjin Huahong Technology Co., Ltd.K253605Safety Heel LancetNingbo Medsun Medical Co., Ltd.K252490Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV)Tianjin Huahong Technology Co., Ltd.K251694safety lancetTianjin Huahong Technology Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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