Question 1

What types of medical devices does Purple Surgical International Limited primarily manufacture?

Accepted Answer

Purple Surgical International Limited specializes in single-use surgical instruments for endoscopic and laparoscopic procedures. Their portfolio includes monopolar electrosurgical handpieces and electrodes for tissue dissection, irrigation and aspiration tubing sets, laparoscopic access cannulas, camera covers, and specialized catheters like salpingographic and uterine manipulation catheters. They also produce dissection sponges, sterile instrument management bags, and various forceps for minimally invasive surgery.

Question 2

Where is Purple Surgical International Limited based, and how does that affect its regulatory compliance?

Accepted Answer

Purple Surgical International Limited is based in the United States. Since the company operates within the U.S., its devices are subject to FDA regulations. The FDA classifies their products as either Class I or Class II, depending on risk level, and these devices are listed in the FDA’s 510(k) and Unique Device Identification (UDI) registries to ensure compliance with U.S. medical device requirements.

Question 3

Which regulatory registries list Purple Surgical International Limited’s devices?

Accepted Answer

Purple Surgical International Limited’s devices are included in the FDA’s 510(k) premarket notification registry and the Unique Device Identification (UDI) system. These registries track devices that have undergone FDA review to demonstrate substantial equivalence to legally marketed predicates, ensuring transparency and compliance with U.S. medical device regulations.

Question 4

How are Purple Surgical International Limited’s devices classified under FDA regulations?

Accepted Answer

The FDA categorizes Purple Surgical International Limited’s devices into Class I or Class II based on their intended use and risk level. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve a higher risk and require special controls to ensure safety and effectiveness. The classification determines the regulatory pathway and oversight required for each product.

Device	Model / Reference	Registries	Class	Status
Laparoscopic Suction / Irrigation set dual spike	PS3800	FDA UDI	Class II	Active
Ultimate Monopolar Scissor	PS3541ULT	FDA UDI	Class II	Active
Auto Shield Trocar Ribbed, plus extra cannula	PS3518	FDA UDI	Class II	Active
Ultimate Lapclinch with ratchet	PS3534ULT	FDA UDI	Class II	Active
Ultimate Suction / Irrigation probe	PS3835ULT	FDA UDI	Class II	Active
Ultimate Intestinal forceps with ratchet	PS3537ULT	FDA UDI	Class II	Active
Ultimate Rat Tooth lapclinch with ratchet	PS3538ULT	FDA UDI	Class II	Active
Universal cannula	PS3507	FDA UDI	Class II	Active
Secondary trocar without Gas Port + Additional Cannula without Gas Port	PS3356	FDA UDI	Class II	Active
Ultimate Straight Grasping Forceps with Ratchet	PS3546ULT	FDA UDI	Class II	Active
Instrument pouch	PS4050	FDA UDI	Class II	Active
Uterine Manipulator / Injector 4, 5mm	PS3111	FDA UDI	Class II	Active
Auto-shield trocar, ribbed cannula plus additional cannula	PS3513	FDA UDI	Class II	Active
Auto-shield trocar, ribbed cannulas plus extra cannulas	PS3509	FDA UDI	Class II	Active
Ultimate Babcock	PS3539ULT	FDA UDI	Class II	Active
Camera sleeve	PS3901	FDA UDI	Class I	Active
Ultimate Monopolar Straight Grasping Forceps	PS3553ULT	FDA UDI	Class II	Active
Secondary Trocar with gas port	PS3305	FDA UDI	Class II	Active
Ultimate Monopolar Intestinal Forceps	PS3587ULT	FDA UDI	Class II	Active
Auto Shield Trocar, Ribbed, plus extra cannula	PS3516	FDA UDI	Class II	Active
Ultimate Monopolar Metzenbaum Scissor	PS3551ULT	FDA UDI	Class II	Active
Secondary trocar with Gas Port + Additional Cannula without Gas Port	PS3357	FDA UDI	Class II	Active
Ultimate Monopolar scissors	PS3531ULT	FDA UDI	Class II	Active
Universal cannula	PS3508	FDA UDI	Class II	Active
Ultimate LapClinch with Ratchet	PS3544ULT	FDA UDI	Class II	Active
Ultimate Monopolar Maryland Dissecting Forceps	PS3552ULT	FDA UDI	Class II	Active
Hasson Trocar	PS3212	FDA UDI	Class II	Active
Ultimate Maryland dissecting forceps	PS3532ULT	FDA UDI	Class II	Active
Auto-shield trocar, ribbed	PS3505	FDA UDI	Class II	Active
Ultimate Maryland Dissecting Forceps	PS3542ULT	FDA UDI	Class II	Active
Ultimate Straight grasping forceps	PS3533ULT	FDA UDI	Class II	Active
Auto-shield trocar, ribbed cannula plus extra cannula	PS3514	FDA UDI	Class II	Active
Hasson Trocar	PS3210	FDA UDI	Class II	Active
Auto-shield trocar, ribbed cannula	PS3515	FDA UDI	Class II	Active
Universal Cannula	PS3506	FDA UDI	Class II	Active
Ultimate Intestinal Forceps with Ratchet	PS3547ULT	FDA UDI	Class II	Active
Ultimate Monopolar Intestinal Forceps with Ratchet	PS3557ULT	FDA UDI	Class II	Active
Auto-shield trocar, ribbed cannula	PS3512	FDA UDI	Class II	Active
Ultimate Monopolar Babcock with ratchet	PS3559ULT	FDA UDI	Class II	Active
Dilating tip trocar, ribbed	PS3415	FDA UDI	Class II	Active
Auto-shield trocar, ribbed cannula	PS3510	FDA UDI	Class II	Active
Laparoscopic Suction/ Irrigation Set single spike	PS3801	FDA UDI	Class II	Active
Ultimate Laparoscopic Suction Irrigation probe, reusable	PS3852ULT	FDA UDI	Class II	Active
Ultimate Rat Tooth LapClinch with Ratchet	PS3548ULT	FDA UDI	Class II	Active
Blunt Dissector - 3 pack	PS3885	FDA UDI	Class I	Active
Secondary Trocar with gas port	PS3307	FDA UDI	Class II	Active
Ultimate Monopolar Rat Tooth LapClinch with Ratchet	PS3558ULT	FDA UDI	Class II	Active
Ultimate Monopolar LapClinch with Ratchet	PS3554ULT	FDA UDI	Class II	Active
Ultimate Monopolar LapClinch without Ratchet	PS3555ULT	FDA UDI	Class II	Active
Dilating tip trocar, ribbed	PS3410	FDA UDI	Class II	Active

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