ClearanceBrief
Panels › Gastroenterology, Urology › Product code GCJ · Class 2

Laparoscope, General & Plastic Surgery

Regulation 876.1500

28510(k)s in 12 months (1,431 all time)
2recalls in 12 months (274 all time)
215recalls that name a 510(k)
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Top companies in GCJ

DateFirm and productCodeLinked 510(k)
Jul 20, 2026Olympus Corporation of the Americas
Olympus 4K UHD LCD Monitor. Model Number: OEV321UH. An electrically powered visual display unit designed for displaying graphical information in color.
Open, Classified
GCJK220069
Jan 2, 2026Applied Medical Resources Corp
Kii Low Profile, Bladed Dual Pack , Qty. 1 5x55mm REF: CTB23
Open, Classified
GCJK060096
Oct 24, 2025Aesculap Inc
Brand Name: AESCULAP Product Name: REDUCING CONVERTER 10/12MM TO 5MM Model/Catalog Number: EK087P Software Version: N/A Product Description: REDUCING CONVERTER 10/12MM TO 5MM Component: N/A
Open, Classified
GCJNone listed
Oct 24, 2025Aesculap Inc
Brand Name: AESCULAP Product Name: SEALING UNIT FOR 10/12MM TROCARS Model/Catalog Number: EK086P Software Version: N/A Product Description: SEALING UNIT FOR 10/12MM TROCARS Component: N/A
Open, Classified
GCJNone listed
Oct 24, 2025Aesculap Inc
Brand Name: Aesculap Product Name: SEALING CAP FOR 10/12MM TROCARS Model/Catalog Number: EK085P Software Version: N/A Product Description: SEALING CAP FOR 10/12MM TROCARS Component: N/A
Open, Classified
GCJNone listed
Oct 24, 2025Aesculap Inc
Brand Name: Aesculap Product Name: SEALING UNIT F/10/12MM TROCARS W.REDUCER Model/Catalog Number: EK083P Software Version: N/A Product Description: SEALING UNIT F/10/12MM TROCARS W.REDUCER Component:
Open, Classified
GCJNone listed
Jul 23, 2025Stryker Corporation
Stryker, StrykeFlow , REF: 0250070500, 2, Disposable Suction/Irrigator without Disposable Tip
Open, Classified
GCJK934094
Sep 30, 2024Carefusion 2200 Inc
Snowden-Pencer MIS DIAMOND-TOUCH DISSECTOR DIAMOND JAW 5MM, 45CM, RATCHETED, REF SP90-7271; endoscopic surgical device
Open, Classified
GCJK930667
Sep 30, 2024Carefusion 2200 Inc
Snowden-Pencer MIS DIAMOND-TOUCH GRASPERS CROCODILE GRASPER, DOUBLE ACTI 5MM, 45CM, RATCHETED HANDLE, REF SP90-7266; endoscopic surgical device
Open, Classified
GCJK930667
Sep 30, 2024Carefusion 2200 Inc
Snowden-Pencer MIS DIAMOND-TOUCH CLAMP DEBAKEY 25 MM JAW 5MM, 45CM, RATCHETED, REF SP90-7243; endoscopic surgical device
Open, Classified
GCJK930667
Sep 30, 2024Carefusion 2200 Inc
Snowden-Pencer MIS DIAMOND-TOUCH ATRAUMATIC GRASPER DIAMOND JAW 5MM, 45CM, RATCHETED, REF SP90-7220; endoscopic surgical device
Open, Classified
GCJK930667
Sep 30, 2024Carefusion 2200 Inc
Snowden-Pencer MIS DIAMOND-TOUCH DISSECTOR DIAMOND JAW 5MM, 32CM, RATCHETED, REF SP90-7071; endoscopic surgical device
Open, Classified
GCJK930667
Sep 30, 2024Carefusion 2200 Inc
Snowden-Pencer MIS DIAMOND-TOUCH GRASPERS CROCODILE GRASPER, DOUBLE ACTI 5MM, 32CM, RATCHETED HANDLE, REF SP90-7066; endoscopic surgical device
Open, Classified
GCJK930667
Sep 30, 2024Carefusion 2200 Inc
Snowden-Pencer MIS DIAMOND-TOUCH GRASPER CRILE CURVED JAW 5MM, 32CM, RATCHETED, REF SP90-7048; endoscopic surgical device
Open, Classified
GCJK930667
Sep 30, 2024Carefusion 2200 Inc
Snowden-Pencer MIS DIAMOND-TOUCH CLAMP BOWEL 60 MM JAW 5MM, 32CM, RATCHETED, REF SP90-7046; endoscopic surgical device
Open, Classified
GCJK930667
Sep 30, 2024Carefusion 2200 Inc
Snowden-Pencer MIS DIAMOND-TOUCH CLAMP BOWEL 50 MM JAW 5MM, 32CM, RATCHETED, REF SP90-7045; endoscopic surgical device
Open, Classified
GCJK930667
Sep 30, 2024Carefusion 2200 Inc
Snowden-Pencer MIS DIAMOND-TOUCH CLAMP DEBAKEY 35 MM JAW 5MM, 32CM, RATCHETED, REF SP90-7044; endoscopic surgical device
Open, Classified
GCJK930667
Sep 30, 2024Carefusion 2200 Inc
Snowden-Pencer MIS DIAMOND-TOUCH CLAMP DEBAKEY 25 MM JAW 5MM, 32CM, RATCHETED, REF SP90-7043; endoscopic surgical device
Open, Classified
GCJK930667
Sep 30, 2024Carefusion 2200 Inc
Snowden-Pencer MIS DIAMOND-TOUCH DISSECTOR FENESTRATED 16MM JAW 5MM, 32CM, NON RATCHETED, REF SP90-7036; endoscopic surgical device
Open, Classified
GCJK930667
Sep 30, 2024Carefusion 2200 Inc
Snowden-Pencer MIS DIAMOND-TOUCH ATRAUMATIC GRASPER DIAMOND JAW 5MM, 32CM, RATCHETED, REF SP90-7020; endoscopic surgical device
Open, Classified
GCJK930667
Sep 30, 2024Carefusion 2200 Inc
Snowden-Pencer MIS DIAMOND-TOUCH GRASPER DIAMOND JAW BABCOCK 5MM, 32CM, RATCHETED, REF SP90-7018; endoscopic surgical device
Open, Classified
GCJK930667
Sep 30, 2024Carefusion 2200 Inc
Snowden-Pencer MIS DIAMOND-TOUCH GRASPER MCKERNAN FUNDUS 5MM, 32CM, RATCHETED, REF SP90-7012; endoscopic surgical device
Open, Classified
GCJK930667
Sep 17, 2024UNIMAX MEDICAL SYSTEMS INC
1. Tech Medical Services Inc. Detachable Endo Retrieval Pouch, REF TM2001, 3" x 6", sterile; 2. Tech Medical Services Inc. Detachable Endo Retrieval Pouch, REF TM2000, 5" x 7", sterile; 3. Tech M
Open, Classified
GCJK103510
Jul 17, 2024Canadian Hospital Specialties Ltd.
Product Name: HIGH FLOW INSUFFLATION TUBING (with Filter) Model/Catalog Number: 20400161S Product Description: Laparoscopic Insufflator
Open, Classified
GCJK001068
Jun 27, 2024ASPEN SURGICAL
Endoscopic Kittner Blunt Dissecting Instrument, Intended to be used for blunt dissection of tissue, Model Number KT-9101
Completed
GCJK913500
Apr 3, 2024Covidien, LP
Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T12BTNL
Open, Classified
GCJK924011
Apr 3, 2024Covidien, LP
Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BT
Open, Classified
GCJK924011
Apr 3, 2024Covidien, LP
Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTS
Open, Classified
GCJK924011
Apr 3, 2024Covidien, LP
Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T12BT
Open, Classified
GCJK924011
Apr 3, 2024Covidien, LP
Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTSNL
Open, Classified
GCJK924011
Apr 3, 2024Covidien, LP
Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTNL
Open, Classified
GCJK924011
Apr 3, 2024Covidien, LP
Covidien Auto Suture" Structural Balloon Trocar, Product Number OMS-T10SB
Open, Classified
GCJK924011
Mar 1, 2024Aesculap Inc
DISP.HASSON TROCAR 12/110MM, Product Code EK240SU. For use in laparoscopic procedures.
Open, Classified
GCJK101937
Mar 1, 2024Aesculap Inc
DISP.TROCAR W.DILATING PIN 12/110MM, Product Code EK236SU. For use in laparoscopic procedures.
Open, Classified
GCJK101937
Mar 1, 2024Aesculap Inc
DISP.TROCAR W.DILATING PIN 12/110MM, Product Code EK234SU. For use in laparoscopic procedures.
Open, Classified
GCJK101937
Mar 1, 2024Aesculap Inc
DISP.HASSON TROCAR 10/110MM, Product Code EK230SU. For use in laparoscopic procedures.
Open, Classified
GCJK101937
Mar 1, 2024Aesculap Inc
DISP.TROCAR W. DILATING PIN 10/110MM, Product Code EK224SU. For use in laparoscopic procedures.
Open, Classified
GCJK101937
Feb 5, 2024CooperSurgical, Inc.
Box as labeled: Regard, Carter-Thomason CloseSure System XL, REF 733776, Quantity 1 Box of 3 Systems. Kit as labeled: Regard, Carter-Thomason CloseSure System, REF 733776, Contents: One (1) Carter-Th
Open, Classified
GCJK980123
May 17, 2023Surgical Innovations Ltd
YelloPort Elite, REF: EO0509505, 5x95 Optical Trocar, Rx Only, SterileR
Open, Classified
GCJK210495
May 17, 2023Surgical Innovations Ltd
YelloPort Elite, REF: EO0507005, 5x70 Optical Trocar, , Rx Only, SterileR
Open, Classified
GCJK210495
Apr 26, 2023Covidien LP
VersaOne Reusable Positioning Cannula 12mm Standard, Model Number RC12STS
Open, Classified
GCJK201805
Apr 26, 2023Covidien LP
VersaOne Reusable Positioning Cannula 11mm Standard, Model Number RC11STS
Open, Classified
GCJK201805
Apr 26, 2023Covidien LP
VersaOne Reusable Positioning Cannula 8 mm Standard, Model Number RC8STS
Open, Classified
GCJK201805
Apr 12, 2023Covidien, LP
Step Bladeless Trocars, 10 mm cannula and dilator with radially expandable sleeve and 5 - 10 mm reducer, Product Number S101010
Open, Classified
GCJK961940
Sep 29, 2022Surgical Innovations Ltd
Product/Part: YelloPort Plus 5x70 Cannula + Luer/YC0507001. For use in laparoscopic procedures.
Open, Classified
GCJK070712
Sep 29, 2022Surgical Innovations Ltd
Product/Part: YelloPort Elite 12x75 Pencil Point Trocar/ET1207503; YelloPort Elite Hasson Adaptor 10mm/EA10NH. For use in laparoscopic procedures.
Open, Classified
GCJK190592
Jun 27, 2022Davol, Inc.
X-Stream Irrigation System (Catalog No. 5551000) and X-Stream Irrigation System Refurbished (Catalog No. 9551000)
Open, Classified
GCJK003790
Jun 7, 2022Davol, Inc.
HydroSurg Plus Laparoscopic Irrigator with Nezhat-Dorsey SmokEvac Trumpet Valve, 33cm Tip and Cojoined Suction and Irrigation Tubing, Catalog Number 0026870
Open, Classified
GCJK961492
Jun 7, 2022Davol, Inc.
HydroSurg Plus Laparoscopic Irrigator with Nezhat-Dorsey SmokEvac Trumpet Valve, Handle only, with Cojoined Suction and Irrigation Tubing, Catalog number 0026880
Open, Classified
GCJK961492
Jun 2, 2022Surgical Innovations Ltd
YelloPort Elite Universal Seal. For use in laparoscopic procedures.
Completed
GCJK190592

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