FDA.reportPublic FDA data

BioCeps Biopsy Forceps

Primary DI
00816207020204
Brand
BioCeps Biopsy Forceps
Company
ENDO-THERAPEUTICS, INC.
Model
ET1402
Catalog number
ET1402
Device description
Endoscopic Biopsy Forceps - Hot
Published
2016-09-22
Public version status
Update
Distribution status
Not 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
KNSUnit, Electrosurgical, Endoscopic (With Or Without Accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNSUnit, Electrosurgical, Endoscopic (With Or Without Accessories)Gastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K800973000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K800973000M.R. ASSOC. HOT BIOPSY FORCEPSMr Associates, Inc.1980-05-08KNS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10816207020201PackageGS110In Commercial Distribution
00816207020204PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081620702020110816207020201
00816207020204008162070202048162070202040816207020204

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic electrosurgical handpiece/electrode, monopolar, single-useA sterile electrosurgical device which consists of a handpiece with mechanical and/or electrical controls, and a monopolar electrode, intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery. It includes a long thin electrode connected to the handpiece and may include a lumen for suction/irrigation; it requires a patient contact return electrode to complete the circuit. It is available in a variety of forms (e.g., forceps or snare with ring handles, rigid probe with controls) and may be designed to also mechanically cut tissues. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length160Centimeter
Outer Diameter2.4Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
844-400-3636customerservice@endotherapeutics.com

Regulatory Flags#

DUNS number
825239189
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
00816207021744EndoTExtractorET2070ET20702026-03-03
10816207021741EndoTExtractorET2070ET20702026-03-03
00816207021386EndoTBasketET2046ET20462025-02-26
10816207021383EndoTBasketET2046ET20462025-02-26
00816207021720Biopsy BrushLBB-95LBB-952025-02-26
00816207020181BioCeps Biopsy ForcepsET1400ET14002016-09-22
00816207020242ezSnare Polypectomy SnareET1800ET18002016-09-22
00816207020259ezSnare Polypectomy SnareET1801ET18012016-09-22
00816207020266ezSnare Polypectomy SnareET1802ET18022016-09-22
00816207020273ezSnare Polypectomy SnareET1803ET18032016-09-22
00816207020280ezSnare Polypectomy SnareET1804ET18042016-09-22
00816207020297ezSnare Polypectomy SnareET1805ET18052016-09-22
00816207020303ezSnare Polypectomy SnareET1806ET18062016-09-22
00816207020310ezSnare Polypectomy SnareET1807ET18072016-09-22
00816207020327ezSnare Polypectomy SnareET1814ET18142016-09-22
00816207020624Polypectomy Snare, Oval-LargeSGO-1315LSGO-1315L2016-09-20
00816207020631Polypectomy Snare, Oval - MediumSGO-1315MSGO-1315M2016-09-20
00816207020648Polypectomy Snare, Oval - SmallSGO-1315SSGO-1315S2016-09-20
00816207020655Polypectomy Snare, Oval - Extra LargeSGO-1315XLSGO-1315XL2016-09-20
00816207020662Polypectomy Snare, Oval - LargeSGO-1622LSGO-1622L2016-09-20

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