FDA.reportPublic FDA data

Biopsy Forceps - Hot

Primary DI
10816207020584
Brand
Biopsy Forceps - Hot
Company
ENDO-THERAPEUTICS, INC.
Model
SG-211-615H
Catalog number
SG-211-615H
Device description
Electrosurgical endoscopic biopsy forceps with Needle
Published
2016-09-20
Public version status
Update
Distribution status
Not 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
10816207020584PackageGS110Not in Commercial Distribution
00816207020587PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081620702058410816207020584
00816207020587008162070205878162070205870816207020587

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic electrosurgical electrode, monopolar, single-useA sterile, invasive, distal component of an electrosurgical assembly intended to deliver electrosurgical current in a monopolar configuration (i.e., used with a patient contact return electrode) to tissues for cutting/coagulation/ablation during endoscopic (e.g., laparoscopic, arthroscopic) surgery. It is available in a variety of forms (e.g., exchangeable electrode for electrosurgical forceps, rigid electrode, flexible endoscopic probe) which may include a lumen for suction/irrigation. It does not include a handpiece or housing and has no electrical or mechanical controls (e.g., does not include ring-handles); it is not intended for gas-enhanced electrosurgery. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length160Centimeter

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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06959664901069NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664901076NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664901595NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664901663NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664901687NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664901700NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664901717NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664902646NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664903520NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664910498NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664910559NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
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06959664910764NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664911921NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664911976NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664911983NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664911990NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664912041NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664912065NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664912072NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664912089NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664912096NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664912102NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664912119NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664919118NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664934036NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664934067NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664934074NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664934098NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17