FDA.reportPublic FDA data

BioCeps Biopsy Forceps

Primary DI
10816207020188
Brand
BioCeps Biopsy Forceps
Company
ENDO-THERAPEUTICS, INC.
Model
ET1400
Catalog number
ET1400
Device description
Endoscopic Biopsy Forceps - Hot
Published
2016-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
10816207020188PackageGS110In Commercial Distribution
00816207020181PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081620702018810816207020188
00816207020181008162070201818162070201810816207020181

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
Length230Centimeter
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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816207021775Biopsy BrushET1424ET14242026-10-07
00816207021782Biopsy BrushET1425ET14252026-10-07
00816207020006EndoTBasketET2031ET20312016-09-22
00816207020013EndoTBasketET2030ET20302016-09-22
00816207020020EndoTBasketET2033ET20332016-09-22
00816207020037EndoTBasketET2032ET20322016-09-22
00816207020044EndoTBasketET2035ET20352016-09-22
00816207020051EndoTBasketET2034ET20342016-09-22
00816207020068EndoTBasketET2040ET20402016-09-22
00816207020075EndoTBasketET2041ET20412016-09-22
00816207020082EndoTBasketET2043ET20432016-09-22
00816207020099EndoTBasketET2042ET20422016-09-22
00816207020112EndoTBasketET2045ET20452016-09-22
00816207020129EndoTBasketET2044ET20442016-09-22
00816207020334EndoTGrasperET2021ET20212016-09-22
00816207020341EndoTGrasperET2022ET20222016-09-22
00816207020952EndoTGrasperET2020ET20202022-09-21
00816207021027Single Use Brush Biopsy InstrumentEGD-160-006EGD-160-0062022-12-09
00816207021041Single Use Brush Biopsy InstrumentEGD-230-006EGD-230-0062022-12-09
00816207021690Single Use Brush Biopsy InstrumentTNE-110TNE-1102022-12-09

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05060359561602FootswitchCREO MEDICAL LIMITEDKNS2026-10-01
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