Atlas FDA

REUSABLE LAPAROSCOPIC INSTRUMENTS

FDA 510(k) clearance K930667 · decided 1994-05-16

Clearance details

K-number
K930667
Device name
REUSABLE LAPAROSCOPIC INSTRUMENTS
Applicant
Snowden-Pencer
Decision
Substantially Equivalent
Date received
1993-02-09
Decision date
1994-05-16
Days to decision
461 days
Clearance type
Traditional
Product code
GCJ
Device class
2
Regulation number
876.1500
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Tucker, GA, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Snowden-Pencer

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
EZ-Close™ (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device) (K253541)Medical Impact2026-07-24
LED LCD Monitor (OEV-271H) (K261614)Lg Electronics.Inc2026-07-17
Universal Seal (5-12 mm) (K261249)Intuitive Surgical, Inc.2026-07-14
FloShield Air System (FSS-01-1000T - 10mm, 0 Degree FloShield Air, FSS-02-1030T - 10mm, 30 Degree FloShield Air, FSS-03-1045T - 10mm, 45 Degree FloShield Air, FSS-01-0500T - 5mm, 0 Degree FloShield Air, FSS-02-0530T - 5mm, 30 Degree FloShield Air, FSS-01-0545T - 5mm, 45 Degree FloShield Air) (K260710)FloShield, Inc.2026-06-11
“Tech-Image” Video Endoscope System (K260414)Tech-Image CO., LTD.2026-06-10
TroKit Laparoscope Lens Wiper (K253994)TroCare, LLC2026-06-04
Inno-Port Disposable Bladed Trocar (K252532)Taiwan Surgical Corporation2026-06-02
4K NIR/ICG Imaging System (K260318)Zhejiang Healnoc Technology Co., Ltd.2026-05-26
MediBot Needle Driver Uno (K260183)Parallel Robotics, LLC2026-05-24
Laport (K252985)Sejong Medical Co., Ltd.2026-05-19
KARL STORZ Trocars with Valve Seals (K254228)Karl Storz SE & CO. KG2026-05-11
4K UHD Endoscopy Camera System (KMS-4K-2088, KMS-4K-2188, KMS-4K-2288) (K252858)Kms Medical Technology Co., Ltd.2026-04-30

Recalls involving this device

RecordFirmDate
Snowden-Pencer MIS DIAMOND-TOUCH GRASPER MCKERNAN FUNDUS 5MM, 32CM, RATCHETED, REF SP90-70 recall (Z-2415-2023)Carefusion 2200 Inc2024-09-30
Snowden-Pencer MIS DIAMOND-TOUCH GRASPER DIAMOND JAW BABCOCK 5MM, 32CM, RATCHETED, REF SP9 recall (Z-2416-2023)Carefusion 2200 Inc2024-09-30
Snowden-Pencer MIS DIAMOND-TOUCH ATRAUMATIC GRASPER DIAMOND JAW 5MM, 32CM, RATCHETED, REF recall (Z-2417-2023)Carefusion 2200 Inc2024-09-30
Snowden-Pencer MIS DIAMOND-TOUCH DISSECTOR FENESTRATED 16MM JAW 5MM, 32CM, NON RATCHETED, recall (Z-2418-2023)Carefusion 2200 Inc2024-09-30
Snowden-Pencer MIS DIAMOND-TOUCH CLAMP DEBAKEY 25 MM JAW 5MM, 32CM, RATCHETED, REF SP90-70 recall (Z-2419-2023)Carefusion 2200 Inc2024-09-30
Snowden-Pencer MIS DIAMOND-TOUCH CLAMP DEBAKEY 35 MM JAW 5MM, 32CM, RATCHETED, REF SP90-70 recall (Z-2420-2023)Carefusion 2200 Inc2024-09-30
Snowden-Pencer MIS DIAMOND-TOUCH CLAMP BOWEL 50 MM JAW 5MM, 32CM, RATCHETED, REF SP90-7045 recall (Z-2421-2023)Carefusion 2200 Inc2024-09-30
Snowden-Pencer MIS DIAMOND-TOUCH CLAMP BOWEL 60 MM JAW 5MM, 32CM, RATCHETED, REF SP90-7046 recall (Z-2422-2023)Carefusion 2200 Inc2024-09-30
Snowden-Pencer MIS DIAMOND-TOUCH GRASPER CRILE CURVED JAW 5MM, 32CM, RATCHETED, REF SP90-7 recall (Z-2423-2023)Carefusion 2200 Inc2024-09-30
Snowden-Pencer MIS DIAMOND-TOUCH GRASPERS CROCODILE GRASPER, DOUBLE ACTI 5MM, 32CM, RATCHE recall (Z-2424-2023)Carefusion 2200 Inc2024-09-30
Snowden-Pencer MIS DIAMOND-TOUCH DISSECTOR DIAMOND JAW 5MM, 32CM, RATCHETED, REF SP90-7071 recall (Z-2425-2023)Carefusion 2200 Inc2024-09-30
Snowden-Pencer MIS DIAMOND-TOUCH ATRAUMATIC GRASPER DIAMOND JAW 5MM, 45CM, RATCHETED, REF recall (Z-2426-2023)Carefusion 2200 Inc2024-09-30
Snowden-Pencer MIS DIAMOND-TOUCH CLAMP DEBAKEY 25 MM JAW 5MM, 45CM, RATCHETED, REF SP90-72 recall (Z-2427-2023)Carefusion 2200 Inc2024-09-30
Snowden-Pencer MIS DIAMOND-TOUCH GRASPERS CROCODILE GRASPER, DOUBLE ACTI 5MM, 45CM, RATCHE recall (Z-2428-2023)Carefusion 2200 Inc2024-09-30
Snowden-Pencer MIS DIAMOND-TOUCH DISSECTOR DIAMOND JAW 5MM, 45CM, RATCHETED, REF SP90-7271 recall (Z-2429-2023)Carefusion 2200 Inc2024-09-30