Question 1

What types of medical devices does Surgical Innovations Limited manufacture?

Accepted Answer

Surgical Innovations Limited specialises in reusable laparoscopic instruments. Their product line includes medical table clamps for securing surgical equipment, monopolar electrosurgical electrodes for endoscopic procedures, reusable laparoscopic access cannulas (such as the YelloPort Elite system), and laparoscopic blunt dissectors. These devices are designed for minimally invasive surgeries, enabling precision and efficiency in procedures like laparoscopy.

Question 2

Where is Surgical Innovations Limited based?

Accepted Answer

The company is headquartered in the United States. This location is relevant for regulatory compliance, as their devices are authorised under U.S. FDA pathways, including the 510(k) premarket notification process and UDI (Unique Device Identification) requirements.

Question 3

Which regulatory registries list Surgical Innovations Limited’s devices?

Accepted Answer

The company’s devices are listed in the FDA’s regulatory databases, specifically under the 510(k) premarket submissions and the UDI (Unique Device Identification) system. These registries ensure transparency and traceability of their Class II medical devices, which undergo evaluation through these pathways before authorisation.

Question 4

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

Accepted Answer

All of Surgical Innovations Limited’s devices fall under FDA Class II classification. This classification indicates moderate risk, requiring pre-market notification (510(k)) to demonstrate substantial equivalence to a legally marketed predicate device. The company’s products, such as the Fastclamp or Logic Laparoscopic Instrument System, must meet specific performance and safety criteria before being authorised.

Question 5

Why are Surgical Innovations Limited’s devices authorised through the 510(k) and UDI pathways?

Accepted Answer

The 510(k) pathway is used for Class II devices to demonstrate that a new device is substantially equivalent to an existing, legally marketed device in terms of safety and effectiveness. The UDI system ensures unique identification of devices throughout their lifecycle, improving tracking, traceability, and post-market surveillance. These pathways are standard for reusable laparoscopic instruments like those from Surgical Innovations Limited, ensuring compliance with U.S. regulatory requirements.

Device	Model / Reference	Registries	Class	Status
YelloPort Plus	YOI1210504	FDA UDI	Class II	Unknown
YelloPort Plus - Laparoscopic Port Access System	YC0515030	FDA UDI	Class II	Unknown
YelloPort Plus - Laparoscopic Port Access System	YC1210522	FDA UDI	Class II	Unknown
Fastclamp	BC-1030-02	FDA UDI	Class II	Active
YelloPort Plus - Laparoscopic Port Access System	YA510STSA	FDA UDI	Class II	Unknown
YelloPort Plus - Laparoscopic Port Access System	YT1010504	FDA UDI	Class II	Unknown
Logi	459-7001	FDA UDI	Class II	Unknown
YelloPort Plus - Laparoscopic Port Access System	YT1215009	FDA UDI	Class II	Unknown
LogiFlex - Laparoscopic Instrument System	120-7200	FDA UDI	Class II	Active
YelloPort	530004R	FDA UDI	Class II	Unknown
YelloPort Plus - Laparoscopic Port Access System	YT1015006	FDA UDI	Class II	Unknown
YelloPort	585021S	FDA UDI	Class II	Unknown
Logic	101-47036	FDA UDI	Class II	Unknown
YelloPort Plus - Laparoscopic Port Access System	YC0507031	FDA UDI	Class II	Unknown
Fastclamp	TC-1000-02	FDA UDI	Class II	Active
YelloPort Plus - Laparoscopic Port Access System	YT1215007	FDA UDI	Class II	Unknown
YelloPort Plus - Laparoscopic Port Access System	YT1210509	FDA UDI	Class II	Unknown
YelloPort Plus - Laparoscopic Port Access System	YA12HS05	FDA UDI	Class II	Unknown
YelloPort Plus - Laparoscopic Port Access System	YC0509531	FDA UDI	Class II	Unknown
YelloPort Plus - Laparoscopic Port Access System	YC0515031	FDA UDI	Class II	Unknown
YelloPort Plus	YA10150LTSH	FDA UDI	Class II	Unknown
Pretzelflex - Surgical Retraction System	SHR7331	FDA UDI	Class II	Unknown
YelloPort Elite - Laparoscopic Port Access System	EC1015020	FDA UDI	Class II	Active
Logic	101-48036	FDA UDI	Class II	Unknown
YelloPort Plus	YA05095CT	FDA UDI	Class II	Unknown
Yelloport	570010	FDA UDI	Class II	Unknown
YelloPort Plus - Laparoscopic Port Access System	YT1215004	FDA UDI	Class II	Unknown
Pretzelflex - Surgical Retraction System	SHR7101	FDA UDI	Class II	Unknown
Fastclamp	IC-1001-02	FDA UDI	Class II	Active
YelloPort Plus - Laparoscopic Port Access System	YA512STSA	FDA UDI	Class II	Unknown
YelloPort Plus	YA05070	FDA UDI	Class II	Unknown
YelloPort Plus - Laparoscopic Port Access System	YA12NH	FDA UDI	Class II	Unknown
YelloPort Plus	YA05095	FDA UDI	Class II	Unknown
YelloPort	550004R	FDA UDI	Class II	Unknown
Logic - Laparoscopic Instrument System	101-7700	FDA UDI	Class II	Active
YelloPort Plus - Laparoscopic Port Access System	YT1010503	FDA UDI	Class II	Unknown
YelloPort Plus - Laparoscopic Port Access System	YT1215006	FDA UDI	Class II	Unknown
YelloPort Plus - Laparoscopic Port Access System	YC0505531	FDA UDI	Class II	Unknown
YelloPort Plus - Laparoscopic Port Access System	YA10NH	FDA UDI	Class II	Unknown
YelloPort Plus - Laparoscopic Port Access System	YC0515032	FDA UDI	Class II	Unknown
YelloPort Plus - Laparoscopic Port Access System	YC1015022	FDA UDI	Class II	Unknown
Logi - Laparoscopic Instrument System	120-7012	FDA UDI	Class II	Unknown
Port Access System	K210495	FDA 510(k)	Class II	Active
Dispos/Reusable Surg Skin/Stainless Steel Staples	K934105	FDA 510(k)	Class II	Active
Laparoscopic Mini-Dissector/Right Angle Retractor	K914098	FDA 510(k)	Class II	Active
Surgical Innovations Disposable Endoscopic Hernia Surgical Stapler Surgical Innovations Resuable Surgical Stapler Handle	K944292	FDA 510(k)	Class II	Active
YelloPort Elite Port Access System	K190592	FDA 510(k)	Class II	Active

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