FDA.reportPublic FDA data

DISPOSABLE BIOPSY FORCEPS

Primary DI
04953170466366
Brand
DISPOSABLE BIOPSY FORCEPS
Company
OLYMPUS MEDICAL SYSTEMS CORP.
Model
FB-211D
Catalog number
N5431840
Published
2025-06-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EOQBronchoscope (Flexible Or Rigid)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EOQBronchoscope (Flexible Or Rigid)Ear, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K250957000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250957000Disposable Biopsy Forceps (FB-211D); Disposable Biopsy Forceps (FB-221D); Disposable Biopsy Forceps (FB-231D); Disposable Biopsy Forceps (FB-241D)Olympus Medical Systems Corporation2025-05-30EOQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14953170466363PackageGS120In Commercial Distribution
04953170466366PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1495317046636314953170466363
04953170466366049531704663664953170466366

GMDN Terms#

Term, Definition table
TermDefinition
Flexible endoscopic biopsy forceps, single-useA flexible, manual, non-electrosurgical instrument intended to obtain tissue specimens during endoscopic procedures (e.g., gastro-urological endoscopy, laparoscopy, bronchoscopy, laryngoscopy) for histopathological examination. It is typically a flexible metal coil with a pair of scissors-like cups with cutting edge rims, which are operated by a control handle at the proximal end of the instrument. It is introduced into the body through an artificial orifice of the body or the working channel of the endoscope. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(800)401-1086xx@xx.xx

Regulatory Flags#

DUNS number
711789789
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04953170437984HALOGEN LAMPMAJ-525N61756012023-04-22
04953170465277AUXILIARY WATER TUBEMAJ-855N34993402025-12-05
04953170452932TRACHEAL INTUBATION FIBERSCOPEOLYMPUS LF-PN44475402022-12-23
04953170437571CONNECTING TUBEMAJ-1503N26450012023-04-22
04953170437588CONNECTING TUBEMAJ-1504N26451012023-04-22
04953170437595CONNECTING TUBEMAJ-1505N26452012023-04-22
04953170437601CONNECTING TUBEMAJ-1508N26453012023-04-22
04953170437625CONNECTING TUBEMAJ-1511N26455012023-04-22
04953170437632CONNECTING TUBEMAJ-1512N26456012023-04-22
04953170437649CONNECTING TUBEMAJ-1513N26457012023-04-22
04953170437656CONNECTING TUBEMAJ-1514N26458012023-04-22
04953170437663CONNECTING TUBEMAJ-1515N26459012023-04-22
04953170437670CONNECTING TUBEMAJ-1516N26460012023-04-22
04953170437687CONNECTING TUBEMAJ-1517N26461012023-04-22
04953170437694CONNECTING TUBEMAJ-1764N30610012023-04-22
04953170437700WATER RESISTANT CAPMD-252N36269012023-04-22
04953170437748Water-resistant capMH-553N36274012023-04-22
04953170438318RETAINING RACKMAJ-840N61790012023-04-22
04953170438325CONNECTOR HANGERMAJ-865N61791012023-04-22
04953170434662ENDOEYE FLEX DEFLECTABLE VIDEOSCOPEOLYMPUS LTF-S190-10N38281332023-04-20

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10810068811527Monarch™ Laptop P16 Software v4.1.1Auris Health, Inc.EOQ2025-06-04
04547410513790FUJIFILMFUJIFILM CORPORATIONEOQ2025-05-31
10810068810988Monarch Platform, Bronchoscopy 4.1Auris Health, Inc.EOQ2025-03-03
10810068810605Monarch™ Laptop P17 Software v4.1.0Auris Health, Inc.EOQ2025-03-03
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