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FDA 510(k)

NINJA SCALPEL

K-Number: K873493 · 1987-09-24

ApplicantPrimrose Medical, Inc.
Decision Date1987-09-24
Product CodeGES
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

NINJA SCALPEL is the device name listed in this FDA 510(k) record. The listed applicant is Primrose Medical, Inc.. It received FDA 510(k) clearance on 1987-09-24 under 510(k) number K873493. The device is classified under product code GES. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NINJA SCALPEL?

NINJA SCALPEL is a medical device that received FDA 510(k) clearance on 1987-09-24. The listed applicant is Primrose Medical, Inc.. The 510(k) number is K873493.

When did NINJA SCALPEL receive FDA 510(k) clearance?

NINJA SCALPEL received FDA 510(k) clearance on 1987-09-24, under 510(k) number K873493.

Who is the listed applicant for NINJA SCALPEL?

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

What is the FDA product code for NINJA SCALPEL?

The FDA product code for NINJA SCALPEL is GES.

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Other records listing Primrose Medical, 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.

K884715ACHELASIA BALLOON DIALATORK884714BILIARY DIALATORK884711URETHRAL AND URETERAL BALLOON DILATATORSK884713COLONIC BALLOON DIALATORSK884712ESOPHAGEAL AND PYLORIC BALLOON DIALATORSK884709ENDOSCOPES & ACCESS.(SCLEROTHERAPY/TRANSBRONCHIAL)

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Related Devices (Code: GES)

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.

K032242PERSONNA PLUS SAFETY SCALPEL SYSTEMOmi Manufacturing Pty., Ltd.K932998EASY-ONDevon Industries, Inc.K923170LOS ALAMOS RETRACTABLE KNIFEInnovative Surgical Technology, Inc.K915119SCALPEL BLADE REMOVER (BLADEGARD)Intergrated Visual, Inc.K911913PRECISION GLIDE - ENHANCED SURGICAL BLADEBd Becton Dickinson Vacutainer Systems PreanalyticK900266STERILE CARBON STEEL SURGICAL BLADERahn Laboratories

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.

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