FDA.reportPublic FDA data

0 Deg 5mm LENSLOCK AC Laparoscope

Primary DI
00856164008167
Brand
0 Deg 5mm LENSLOCK AC Laparoscope
Company
Poc
Model
5281-900
Device description
The POC endoscope is intended use for endoscopic viewing of internal surgery sites during minimally invasive surgery in the peritoneal cavity, thoracic cavity, and peritoneum. It is designed for use with endoscopic instrument control systems during laparoscopic and thoracoscopic surgical procedures.
Published
2021-03-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GCJLaparoscope, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K914084000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K914084000ENDOSCOPESPrecise Optics1992-01-22GCJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00856164008167PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00856164008167008561640081678561640081670856164008167

GMDN Terms#

Term, Definition table
TermDefinition
Rigid optical laparoscopeAn endoscope with a rigid inserted portionangulus iridocornealis for the visual examination and treatment of the abdominal/retroperitoneal cavity and its organs. It is inserted through an incision made in the abdominal wall (routinely just below the umbilicus) during laparoscopy. Anatomical images are transmitted to the user by the device through relayed lens optics or a fibreoptic bundle. The abdominal wall is distended, typically using a gas, providing the space to allow the surgeon to view and/or operate on the exposed organs. This reusable device is commonly used to evaluate/treat abdominal or pelvic pain, ectopic pregnancy, ovarian cysts, appendicitis, and perform female sterilization.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
118244987
Device count
1
Lot or batch
true
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
0085616400800630 Deg 10mm AC Lap POC6713-9016713-8012021-03-23
008561640080130 Deg 10mm Laparoscope Assembly POC6711-9012021-03-23
0085616400818130 Deg 4mm AC Arthroscope5250-9012021-03-23
008561640081980 Deg 4mm AC Arthroscope5250-9022021-03-23
0085616400802030 Deg 5mm POC Laparoscope Assy6753-9012021-03-23
008561640080820 Deg 5mm POC AC Laparoscope Assy6751-9012021-03-23
008561640081430 Deg 10mm 425mm Lg, Laparoscope6761-9032021-03-23
0085616400815030 Deg 10mm 425mm Lg., Laparoscope6763-9042021-03-23
0085616400817418 Deg 5mm x 407mm Laparoscope8332-9002021-03-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776422745MillenniumAvalign Technologies, Inc.GCJ2026-08-03
00190776422752MillenniumAvalign Technologies, Inc.GCJ2026-08-03
04026704934812TELEFLEXTELEFLEX INCORPORATEDGCJ2026-08-03
B382SD4131490Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
B382SD4162910Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
B382SD49245120Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
B382SD55670280Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
B382SD56325330Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
B382SD56400150Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
B382SD56534210Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
B382SD567910130Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
B382SD56914330Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
00190776421960MillenniumAvalign Technologies, Inc.GCJ2026-07-31
00190776422325MillenniumAvalign Technologies, Inc.GCJ2026-07-31
00888867498105Arthrex®ARTHREX, INC.GCJ2026-07-31
14026704921741TELEFLEXTELEFLEX INCORPORATEDGCJ2026-07-31
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B382SD13798130Surgical DirectSurgical Direct, Inc.GCJ2026-07-31
B382SD14678780Surgical DirectSurgical Direct, Inc.GCJ2026-07-31
B382SD15378970Surgical DirectSurgical Direct, Inc.GCJ2026-07-31
B382SD15458990Surgical DirectSurgical Direct, Inc.GCJ2026-07-31
B382SD161090Surgical DirectSurgical Direct, Inc.GCJ2026-07-31
B382SD169920Surgical DirectSurgical Direct, Inc.GCJ2026-07-31
B382SD30109760Surgical DirectSurgical Direct, Inc.GCJ2026-07-31
00198506092183ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-07-29
00198506092640ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-07-29
00198506093562ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-07-29
00198506093838ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-07-29
B354OSRP80Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-07-29
00198506092435ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-07-28